Q4 2023 HeartBeam Inc Earnings Call
Speaker Change: [music].
Operator: Greetings and welcome to the Heartbeam fourth quarter and full year 2023 financial results. 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 broadcast over the Internet. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include... Estimates, or other information that While these four forward-looking statements represent our current judgment on what, they are subject to risks and are. You are cautioned not to place undue reliance on these four, which reflect our opinions only as of the date of this presentation.
Greetings and welcome to the Heartbeat fourth quarter and full year 2023 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 before we begin the formal presentation I would like to remind everyone that statements made on the call and webcast.
Predictions estimates or other information that might be.
To 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.
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 our or publicly release the results of any revision to these forward looking statements in light of new information or future events throughout today's discussion we will attempt to present.
Operator: Please keep in mind that we are not obligating ourselves to revise our positions or publicly release any revision, in light of new information, throughout today's discussion. We will attempt to Important Factors Relating to, That may affect our We should also review our most recent Form 10-K and Form, For more complete discussion of these factors, please visit www.heartbeamheart.com, particularly under the, Fresh release detailing these results across the wire just after, and is available in the investment relations section of our website. Heart. Your host today is Branislav Vajdic. Executive Officer and Founder, Rob E. President Deborah Kastanis
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 wire. This afternoon and is available in the Investor Relations section of our company's website heartbeat Dot com.
Your host today branch loves Magic.
Executive Officer, and founder Rob You know president.
Broke his deal.
Branislav Vajdic: President, Regulatory Affairs, and Rick Brown, Chief Financial Officer. Present Results of Operations for the Fourth Quarter and Full Year End. At this time, I will turn the call over to Heartbeam, Branislav. Thank you, operator. I'd like to start by giving a brief overview of Heartbeam and our technology. It is really important to understand how our ECG technology is different, and lastly, more powerful than the most common personal ECG technologies that are out there in the marketplace today. A 12-lead ECG is one of the most commonly performed diagnostic tests in the; it is actually a standard in hospitals and clinics. There are many ECG technologies that can be used by patients or consumers at home. You can see a couple of examples on this slide.
Branch Love: President of regulatory affairs, and with Boston Consulting Chief Financial Officer will present, the results of operations for the fourth quarter and full year ended December 31, 2023, and this time I will turn the call over to Heartbeat, Chief Executive Officer branch off right each.
Heartbeat: Thank you operator.
Heartbeat: I'd like to start, but you get a brief overview of all heartbeat.
Heartbeat: It is really important to understand how all of the game technology's difference.
Speaker Change: Lastly, more powerful.
Heartbeat: The most common first of all he's Egypt anthology that all.
Heartbeat: In the marketplace today.
Heartbeat: H lovely ECG E.
Heartbeat: One of the most commonly performed diagnostic test.
Heartbeat: Yes, it's actually a standalone hospitals and clinics.
Many gigs apologies that can be used by patients or consumers at home.
Heartbeat: You can see a couple of examples on this slide.
Branislav Vajdic: There are not any well-leading CGs. Instead, there are one lead, three leads, or six leads. This is adequate for detecting many arrhythmias, but it is not sufficient for detecting a heart attack or complex arrhythmias. In contrast, the Heartbeam Amigo is an easy-to-use, third-card-sized system that synthesizes a 12-ADC gene. It is a health care device. We know it's electrodes or wires, and it is easy for the patient to apply.
Heartbeat: That lead ECG instead, they are wildly really those 60.
Heartbeat: This is adequate.
Heartbeat: Perfect.
Heartbeat: Yes.
Heartbeat: It is not sufficient.
Or is it half of that or complex arrhythmias.
Heartbeat: Okay.
Heartbeat: Contest the hockey and Amy go.
Heartbeat: And easy to use they've gotten size system.
Heartbeat: Besides Asahi ECG.
Heartbeat: Uh huh.
Heartbeat: So device.
Heartbeat: No.
Heartbeat: It's all buyers.
Heartbeat: It's easy for the patient to a block.
Branislav Vajdic: The key aim of the Heartbeam technology is to quickly and accurately help clinicians identify the full range of cardiac conditions, including a heart attack, outside of a medical facility. Our proprietary 3D VECG technology offers higher resolution monitoring by capturing heart activity in three projections X, Y, and Z, which can provide for many cardiac conditions a more complete view of the heart than a standard therapeutic ECG. The Amygo device, coupled with a smartphone app and cloud-based diagnostic software, enables remote evaluation of cardiac symptoms by physicians, and we believe it could reduce the critical time to intervention for heart attack patients. Since the average patient waits three to four hours before seeking care, shortening their time from symptoms to the door of a medical institution would reduce complications and save many lives. In addition, more than 80% of patients with chest pain who go to the emergency room are not having a heart attack.
Heartbeat: The key aim of the economy.
Heartbeat: Just to quickly and accurately so clinicians.
Heartbeat: Before the closing.
Heartbeat: Closing a heart attack.
And outside the medical so soon.
Heartbeat: Our proprietary.
Heartbeat: <unk> technology offers high but it is also monitoring like Jeff.
Heartbeat: Hi.
Heartbeat: Pete.
Heartbeat: The objections X y Z.
Speaker Change: We can provide for many conditions a more complete view of the hard data standards certainly ECG.
Speaker Change: The Amy go device.
Speaker Change: Helpful.
Speaker Change: Mark.
Speaker Change: And cloud based diagnostic software enables.
Speaker Change: Both evaluation of <unk> and.
And we believe it could reduce the physical side.
Speaker Change: For heart attack patients.
Speaker Change: The average patient base.
Speaker Change: Before.
Speaker Change: Sure.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: The door or let it go.
Speaker Change: Joseph will reduce complications and save many lives.
Speaker Change: In addition.
Speaker Change: More than 80% of patients with chest pain.
Speaker Change: What are the budgets.
Speaker Change: Not having a heart attack.
Branislav Vajdic: 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. So why do we think that an easy-to-use 12-week ECG with patients is transformational? Well, first, having the ability for patients to take frequent family readings over time and in a variety of real-life situations potentially has huge diagnostic value. For instance, whenever a patient is feeling symptoms, they can get a 12-lead reading that will be reviewed by a physician.
Speaker Change: And then secondly, Riyadh school.
Speaker Change: So that patient was.
Speaker Change: It used the number of unnecessary emergency room visits.
Speaker Change: Cost the healthcare system.
Speaker Change: So why do we think they're easy to use that we ECG based.
Speaker Change: Patients.
Speaker Change: Information.
Speaker Change: Well first.
Speaker Change: The ability for patients to take leases sadly.
Speaker Change: Overtime.
Speaker Change: In a variety of realized situations potentially is huge diagnostic side.
Speaker Change: Whenever the patient is feeling symptoms.
Speaker Change: Yes.
Speaker Change: This will be used by a physician.
Branislav Vajdic: Secondly, trending K12 EDCG, both symptomatic and asymptomatic, over time will allow physicians to gain insight to help guide cardiac care. Frequent ECGs to create this trending are simply not feasible today. And finally, as we will discuss in more detail, combining deep learning algorithms with a large number of longitudinally created VECGs has the potential to create an unparalleled predictive, per diagnostic algorithm. As a result, we have the opportunity to address not only artery fibrillation markets but also foreign artery disease markets, which are about six times larger. In the United States, there are approximately 3,000,080 patients representing a $2 billion market. There are approximately 20 million total coronary artery disease patients, which is a $12 billion market. So the overall opportunity in the U.S. is only about $14 billion.
Speaker Change: Secondly, so ending <unk>.
Speaker Change: Symptomatic and eight.
Speaker Change: Overtime.
Speaker Change: We will allow physicians to gain insight to help guide target.
Speaker Change: So you can see we ecg's cadence.
Speaker Change: He is simply not feasible today.
Speaker Change: And finally <unk>.
Speaker Change: We will discuss in more detail.
Speaker Change: Deep learning.
Speaker Change: Yes.
Speaker Change: A large number of longitude at <unk> <unk>.
Speaker Change: The potential to create.
Speaker Change: Okay.
Speaker Change: And then lastly.
Speaker Change: Operator.
Speaker Change: We have the opportunity to address not only partially if we blazer markets, but also for the office market, which is about six times larger.
Speaker Change: The United States box.
Speaker Change: Approximately three media 80 patients.
Speaker Change: Has there been a 2 billion dollar margins.
Speaker Change: There are approximately 12 new media.
Speaker Change: Total quarterly obviously.
Speaker Change: These patients which is.
Speaker Change: Really up market.
Speaker Change: So the overall opportunity in the U S Army is about $14 billion.
Robert Eno: I'd like to now turn the call over to Rob Eno, our president. Thanks, Branislav. We wanted to give an update on our progress related to Amy Go. Our initial clearance for the Amygo system will be a major milestone for the company, and it's important for many reasons. To start, we expect this to be the first patient-held 3D VECG device to be cleared by the FDA. Also, this clearance will be the basis for further FDA submissions for Heartbeam, so it's the cornerstone of our effort. The 3D VECG approach is an excellent platform for AI algorithms.
Speaker Change: Yeah.
Speaker Change: I'd like to turn the call over to Rob <unk>, our president.
Rob: Thanks Brent.
We wanted to give you an update on our progress related to Amy go.
Rob: Our initial clearance for the <unk> system will be a major milestone for the company and its important for many reasons.
Rob: To start we expect this to be the first patient held three D V ECG device to be cleared by the FDA.
Rob: Also this clearance will be the basis for further FDA submissions for heart beam, So which is the cornerstone of our efforts.
Rob: The three D V. ECG approach is an excellent platform for AI algorithms. We are a major AI effort underway. We're encouraged about the progress and the initial results we presented at scientific meetings in Q2.
Robert Eno: We have a major AI effort underway, and we're encouraged about the progress and the initial results we presented at scientific meetings in Q2. In the longer run, we believe that applying AI algorithms on top of the rich VECG data, especially with longitudinal data sets for patients taking readings monthly, weekly, or even more frequently, could result in unsurpassed predictive and diagnostic accuracy. In addition, there is significant clinical research over several decades that demonstrates the diagnostic value of a VCG approach.
Rob: In the longer run, we believe that applying AI algorithms on top of the rich the ECG data, especially with longitudinal datasets for patients taking readings monthly weekly or even more frequently could result, an unsurpassed predictive and diagnostic capabilities.
Rob: In addition, there is significant clinical research over several decades that demonstrates the diagnostic value of ECG approach by capturing the hearts vectors in three dimensions theres, even more diagnostic information available than in the standard 12 week.
Debbie Castillo: By capturing the heart vectors in three dimensions, there is even more diagnostic information available than in the standard 12. And our landmark study summarized here that was published in Jack Advances in August of last year showed that the Amygo VECG technology had similar diagnostic ability as a 12-lead ECG in detecting coronary occlusion, 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. And with that, I'd like to introduce Debbie Castillo to give an update on our regulatory affairs. Debbie is Heartbeam's Vice President of Regulatory Affairs. She holds a Ph.
Rob: And our landmark study summarized here that was published in JAK advances in August of last year showed that the Amy go the ECG technology had similar diagnostic ability is a 12 lead ECG and detecting coronary inclusions and adding a baseline reading for comparison, which is a crucial part of our system.
Rob: <unk> and significantly better accuracy and a single 12 lead ECG.
Rob: And with that I'd like to introduce Debbie Castillo to give an update on our regulatory efforts Debbie as heart teams Vice President of regulatory she holds a Phd in biomedical engineering from Johns Hopkins University and has extensive experience in regulatory affairs and industry and also at the U S food and drug administration, where she held <unk>.
Debbie Castillo: D. in biomedical engineering from Johns Hopkins University and has extensive experience in regulatory affairs in industry and also at the U.S. Food and Drug Administration, where she held various roles, including senior lead reviewer, lead scientific reviewer, and acting chief of the cardiac device. Thank you, Rob. As a reminder, we have a 510k application under review with FDA for our Amy Go 3D VECG system. This application includes our 3D VECG credit card-sized device that records cardiac activity from the XYZ projections and displays the signals for clinician review. The system also includes a patient application, a physician portal, and wireless communication among the elements.
Debbie Castillo: <unk> roles, including senior lead reviewer lead scientific reviewer and acting chief of the cardiac devices branch.
Debbie Castillo: Thank you Rob.
Debbie Castillo: As a reminder, we have a starting pay application under review with that call for Amy go <unk>.
Debbie Castillo: This application includes our three D E.
Debbie Castillo: Credit card size device that may cause cardiac activity some of the X Y Z projections and displays to 10 minutes for a clinician review.
Speaker Change: I think with the patient application.
Speaker Change: Oh and wireless communication among the elements.
Debbie Castillo: As Rob mentioned, this is the cornerstone submission for Heartbeam and will be the basis of future regulatory efforts. We submitted this 510K application in the second quarter of 2023. The review remains active with FDA as we have successfully passed the acceptance of the filing and have completed the initial substantive review phase with questions and requests from FDA. 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. We have conducted the agreed-upon testing to address FDA's open questions and are in the process of preparing our official response. Once these are submitted, the FDA will complete the review of our 510k.
Speaker Change: As Rob mentioned this is the cornerstone commission for heartburn, and what will be the basis of future regulatory assets.
Speaker Change: We submitted this five turnkey application in the second quarter of 2020 through the review remains active with FDA as we have successfully passed the acceptance of the filing and have completed the initial substantive review full with questions and requests for some kind of cool.
Speaker Change: As we continue to navigate the privates towards clearance, we have taken advantage of all available regulatory tools and opportunity to work interactively with SBA, gaining valuable official communication and feedback on our proposed response approach, including our testing protocols we.
Speaker Change: We have conducted the agreed upon testing to address the theaters open questions and are in the process of preparing our official responses.
Speaker Change: Once these estimated that they will complete their review of our five 10-K.
Debbie Castillo: We currently are anticipating clearance by the end of quarter two of 2024. I also want to touch on our second FDA submission. Following, of course, the clearance of the Amigo 3D VECG system, we will be working to obtain a second 510K clearance. The second 510K will be focused on the ability to offer the physician a pair of baseline and symptomatic 12 lead ECGs, both of which are synthesized from the 3D VECG signals, the XYZ, recorded by the Heartbeam Amigo device. This approach leverages recently issued patents for a personalized system for synthesizing 12-lead ECG wafers.
Speaker Change: We currently are anticipating clearance by end of Q.
Speaker Change: Our 2024.
Speaker Change: I also wanted to touch on our second half off promotion following of course, the clearance of <unk> system, we will be working to obtain a second platform Cogs. The second five 10-K will be focused on the ability to offer the physician a pair of baseline and symptomatic 12 lead E C. G.
Speaker Change: All of which are central to synthesize from the <unk> The X Y Z recorded by the Heartbeat Amy go device.
Approach Leverages recently issued patents for a personalized system quite synthesizing wildly ECG waveforms.
Robert Eno: The second Platkin K application is planned to be submitted to FDA by quarter three of 2024. A key part of the submission will be a pivotal study named our valid ECG study, which will demonstrate the similarities between the synthesized 12-lead output from Amigo and a simultaneously recorded standard 12-lead ECG. Today, we have held two pre-submissions meetings with FDA on this 12-lead synthesis submission. These meetings have been focused primarily on the performance goals of our proposed pivotal clinical study. Rob will now discuss the details of the pivotal steps. Thanks, Debbie.
Speaker Change: The second question Capitation is planned to be submitted to FDA by quarter three of 2024, a key part of this submission will be a pivotal study named are valid ECG study, which will demonstrate the similarity.
Speaker Change: Synthesize 12 lead output from Amy go any simultaneously recorded standard 12 lead ECG.
Speaker Change: Today, we have held two pre submission meetings with FDA on this 12 Lucentis submission.
Speaker Change: <unk> has been focused primarily on the performance goals of our proposed pivotal clinical study.
Speaker Change: Rob will now discuss the details of the pivotal.
Rob: Thanks, Debbie based on feedback from FDA and our clinical experts we've designed our clinical study the valid ECG study as we announced last week, we've enrolled the first patients in this study which is designed to validate the Amy go 12 lead ECG synthesis software by comparing it.
Robert Eno: Based on feedback from FDA and our clinical experts, we've designed our clinical study, the Validated ECG. As we announced last week, we've enrolled the first patients in this study, which is designed to validate the Amygo 12-lead ECG synthesis software by comparing its results with those of a standard hospital-based, FDA-cleared 12-lead ECG using both quantitative and qualitative assessment methodologies. We plan to enroll approximately 198 patients presenting to an outpatient cardiology clinic or arrhythmia center with symptoms suggestive of cardiac arrhythmia or for a routine checkup of previously diagnosed arrhythmia. The study is expected to include up to five sites in the U.S.
Rob: <unk> results with those of our standard hospital based FTA cleared 12 lead ECG using both quantitative and qualitative assessment methodologies, we plan to enroll approximately 198 patients presenting to an outpatient cardiology clinic or arrhythmia center with symptoms suggestive of cardiac.
Rob: Arrhythmia or for routine checkup have previously diagnosed arrhythmia.
Rob: The study is expected to include up to five sites in the U S.
Branislav Vajdic: The primary objective is to demonstrate the similarities of ECG waveforms between Amy Goh's synthesized 12-lead ECG and a standard 12-lead ECG recorded simultaneously in each subject by assessing intervals and amplitudes. In preparation for this pivotal study, we completed an 80-patient pilot study that mirrors the pivotal study. Based on these pilot results, we initiated the VALID-ECG study. We anticipate completion of enrollment in the ValidECG study in Q2 2024 and submission of the second 510K application by Q3 2024. We continue to anticipate that our limited launch of AmyGo will occur by the end of 2020. Now I'd like to turn it back to Branislav for an update on our AI. Thanks, Rob.
Rob: The primary objective is to demonstrate the similarities of ECG wave forms between Amy goes synthesize 12 lead ECG and a standard 12, we'd ECG recorded simultaneously and each subject by assessing intervals and amplitudes.
Rob: In preparation for this pivotal study we completed an 80 patient pilot study, which mirrors. The pivotal study based on these pilot results we initiated the valid ECG study.
Rob: We anticipate completion of enrollment and the valid ECG study in Q2 2024 and submission of the second 500 10-K application by Q3 2024.
Rob: We continue to anticipate that our limited launch of Amy go will occur by the end of 2024.
Brenda Starve: Now I'd like to turn it back to Brenda starve for an update on our AI efforts.
Brenda Starve: Thanks, Rob.
Branislav Vajdic: As we discussed last quarter, we have an active artificial intelligence program underway. Our AI team includes five PhDs. The leadership has deep AI expertise experience, including positions at Apple, Microsoft, and Google. We have acquired approximately 1,000,012 ADCGs from various sources, a key element in our fast-paced development. We have developed initial deep learning algorithms focused on the ability to detect various cardiac arrhythmias, and we had data of these deep learning algorithms accepted for presentation, out in Boston in May.
Brenda Starve: We discussed last quarter recap of that you'd love to Vishal Tele jet program underway.
Brenda Starve: AIP includes five <unk> the leadership has deep.
Expertise experience, including positions at Apple, Microsoft and Google.
Brenda Starve: <unk> acquired approximately $1 million <unk> co. Various sources are key element in our SaaS based development efforts.
Brenda Starve: We have developed initial deep learning dog wafers focus of the FDA.
Brenda Starve: Yes, yes.
Brenda Starve: D J D.
Brenda Starve: Deep learning nobody does.
Speaker Change: Well presentation.
Speaker Change: I'll be in Boston in May.
Branislav Vajdic: We believe that when combined with our credit card-sided Amygo3d 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, and the potential to further enhance the user experience and simplify the onboarding process. And finally, in the longer run, we believe that applying deep learning algorithms on top of the rich VECG data that you obtain from our Amygo device, especially with the longitudinal data sets from patients taking pieces, and recordings, could result in an unparalleled predictive and diagnostic capability. Turning to intellectual property, we have recently received two additional U.S. patents, enhancing our already strong IP portfolio. As you have heard, our current focus is on the credit side. Amygo system with the ability to create a 3D VEC chip signal in a small, easy-to-use, easy-to-carry four-factor. This will be followed by a second clearance on the ability to synthesize an ECG from these signals. In addition, there are additional four factors covered by our IP, first in an RV van. 12-Week Extended Pass
Speaker Change: We believe that when combined with our head cut side.
Speaker Change: <unk> technology has.
Speaker Change: AI will provide additional value to patients and physicians in that number.
Speaker Change: It's included.
Providing automated classification of cardiac conditions, including commentary yes.
Speaker Change: The potential to further enhance the user experience and simplify the onboarding process.
And finally in the long run we believe this applying deep learning algorithms on top of the <unk> data.
Speaker Change: Obtained from our indigo device.
Speaker Change: So it would be the logic to the last data set from patient safety.
Speaker Change: Reported.
Speaker Change: Could result in the unparalleled.
Speaker Change: Diagnostic capability.
Speaker Change: Turning to IP, we have recently received two additional U S patents.
Speaker Change: Our already strong.
Speaker Change: Portfolio.
Speaker Change: As you have for our current focus is on the credit side.
Amy system ecosystem with the ability to create that <unk> see though in a small <unk>.
Speaker Change: Is it to use easy for kitted floor factor.
Speaker Change: This will be followed by a second.
Speaker Change: Yeah.
Speaker Change: The ability to synthesize that.
Speaker Change: ECG DC boats.
Speaker Change: In addition.
Speaker Change: There are additional form factors covenants, but our IP.
Speaker Change: First.
Speaker Change: And then all of the bed.
Speaker Change: Well, we've extended patch, we have a opportunity to.
Branislav Vajdic: We have an opportunity to take the usual one-lead signal that's obtained from the patches much further and actually offer a 12-lead. This would operate similarly to current extended cardiac monitors, such as extended halters or model cardiac telemetry, known as MCOT as well. But using the Amygo technology, a patient would simply place two fingers on the top of the device, which will enable thorough breathing, something that is really not possible today with any kind of patch that's in the market.
Speaker Change: To date, the usual wildly seatbelt obtained for the back much.
Speaker Change: Much further and lastly, the offer itself.
Speaker Change: This would operate similarly to current extended their cognate bodies, such as extended its holders or marvell targets.
Speaker Change: Notice and thoughts as well.
Speaker Change: But using the Amy go technology Ah patients would simply place two fingers.
Speaker Change: On the top of the device, which will enable us readings.
Speaker Change: Something that is really not possible today any type of patch that's in the marketplace.
Branislav Vajdic: Secondly, our integrated system combines AIMEGO with continuous monitoring. We have multiple patents granted to our Read More watch, which is the first FDA-cleared prescription variable for continuous cardiocritical monitoring. And finally, our IP allows a 12-watt, that is actually a combination of the functionality of a wearable ECG that provides continuous monitoring with an on-demand family D.C. Our patents cover a 20 BCG watch, so that when the watch detects abnormalities, the patient can remove the watch and simply place it on the chest, activating the ProEDCG.
Speaker Change: Secondly, our integrated system combines Amy go read the continuous monitor.
Speaker Change: We have multiple patents granted to our lead more watch.
Which is the first FDA cleared subscription variable.
Speaker Change: Continuous Scott.
Speaker Change: Understood.
Speaker Change: And finally <unk>.
Sure.
Speaker Change: <unk> allows <unk> watch.
Speaker Change: This is actually a combination of functionality or thereabout ECG.
Does it provide continuous monitoring.
And on demand so we'd ECG.
Speaker Change: Our patents cover <unk> watch.
Speaker Change: The watch the task of the allowances.
Speaker Change: Patients can remove the watch and simply replacing all of the chest.
Speaker Change: Yes.
Speaker Change: <unk>.
Branislav Vajdic: We plan to pursue all options in the development of these products, including the possibility of collaborating with leaders in the ECG and wearable fields. I'd like now to turn the call over to our consultant CFO, Rick Brounstein. Thank you, Branislav.
Speaker Change: We plan to pursue all options in the development of these products, including the possibility of collaborating with leaders in the ECG and variable fields.
Speaker Change: Yeah.
Speaker Change: I'd like now.
CFO broski: The call over to our consultants CFO broski.
CFO broski: Thank you Brian.
Richard D. Brounstein: Turning now to our financials, I will give a brief review of our financial results. A full breakdown is available in our regulatory filings and the press release that just crossed the wire after the closing market today. General and administrative expenses for the fourth quarter of 2023 and 2022 were both $2.1 million.
CFO broski: Turning now to our financials I will give a brief review of our financial results.
CFO broski: A full breakdown is available in our regulatory filings and the press release that just crossed the wire after the close of market today.
CFO broski: General and administrative expenses for the fourth quarter of 2023, and 2022 are both $2 1 million.
Richard D. Brounstein: For the year ended December 31st, 2023, GNA expensed increased 1.2 million, to 8.5 million compared to 7.3 million in the same period of 2022. The increase is primarily related to non-cash, stock-based compensation expense amounting to $1.6 million, that was associated with additional awards granted since December 31st, 2022. Resulting primarily from the issuance of employee stock options following the May 2023 financial, Our cash spending is actually down in fiscal 2023 compared to fiscal 2022, of note in 2022, we had invested in the commercial team. And due to our change in our near-term focus in early 2023, we are not currently emphasizing commercial activities as we proceed through the FDA clearance process, for HeartBeam AME. Research and development expenses for the fourth quarter of 2023 were $2 million, compared to $1.6 million for the fourth quarter of 2022, for the year ended December 31st, 2023 research and development expenses, which increased 1.1 million to 6.8 million, compared to $5.7 million in the prior year are also due to the increase in non-cash stock-based compensation expense, as well as the increase in headcount and professional services supporting the FDA clearance process, primarily offset by completion of initial development in 2022 of the platform for Amy Green.
CFO broski: For the year ended December 31, 2023, any G&A expense increased $1 2 million.
CFO broski: $8 5 million compared to $7 3 million in the same period of 2022.
CFO broski: The increase is primarily related to noncash stock based compensation expense amounting to $1 6 million.
CFO broski: It was associated with additional awards granted since December 31 2022.
CFO broski: Resulting primarily from the issuance of employee stock options. Following the May 2023 financials.
CFO broski: Our cash spending is actually down in fiscal 2023 compared to fiscal 2022.
CFO broski: Of note in 2022, we had invested in the commercial team.
CFO broski: And due to our change in our near term focus in early 2023.
CFO broski: Currently emphasizing commercial activities as we proceed through the FDA clearance process for heart female Nicole.
CFO broski: Research and development expenses for the fourth quarter of 2023 were $10 million.
CFO broski: <unk> to $1 6 million for the fourth quarter of 2022.
CFO broski: For the year ended December 31, 2023 research and development expenses, which increased $1 1 million to $6 8 million.
CFO broski: <unk> to $5 7 million in the prior year are also due to the increase in non stacks and sorry in noncash stock based compensation expense.
CFO broski: As well as the increase in head count and professional services supporting the FDA clearance process.
Primarily offset by completion of initial development in 2022 of the platform for Amigo.
Richard D. Brounstein: Our cash and cash equivalents are conservatively invested in treasuries with a duration of up to three months. With 2023 interest rates in the short-term markets around 5%, we earned $675,000 in interest income in fiscal 23, compared to $66,000 in fiscal 2022, as a result of our increased cash balance following the 26.5 million dollar financings in May of 2023, coupled with these higher. The net loss for the full year of 2023 was $14.6 million, compared to a net loss of $13 million for the full year of 2022. We ended 2023 ahead of plan with 16.2 million in cash and cash equivalents as of December 31, 2023, compared to 3.6 million as of December 31st, 2022. As mentioned, in May, we closed common stock financing with gross proceeds of $26.5 million.
CFO broski: Our cash and cash equivalents are conservatively invested in treasuries with the duration of up to three months.
CFO broski: With 2023 interest rates in the short term markets around 5%, we earned $675000 in interest income in fiscal 'twenty three compared to 66000 in fiscal 2022.
CFO broski: As a result of our increased cash balance following there.
CFO broski: $26 $5 million of financings in May of 2023, coupled with these higher interest rates.
CFO broski: Net loss for the full year of 2023 was $114 6 million compared to a net loss of $13 million for the full year 2022.
CFO broski: We ended 2023 ahead of plan was $16 2 million in cash and cash equivalents as of December 31, 2023, compared to $3 6 million as of December 31, 2022.
CFO broski: As mentioned in May we closed common stock financing with gross proceeds of $26 5 million.
CFO broski: Cash is anticipated to last into early 2025.
CFO broski: We anticipate to begin a limited launch of <unk> by the end of 2024.
Richard D. Brounstein: This cash is anticipated to last into early 2025, while we anticipate to begin the limited launch of Amygo by the end of 2025. Head Casting and Operating Activities in the fourth quarter of 2023 were approximately 2.9. We remain confident that we have sufficient funds to deliver on our milestones and get prepared to move into the commercialization phase of Heartbeat Media. And finally, as I said before, it's worth emphasizing that the May 2023 financings were common stock only, and they did not include any warrants in our balance sheet as a result. As a very simple and straightforward capital structure, with approximately 26 million shares.
CFO broski: Net cash used in operating activities in the fourth quarter of 2023 was approximately $2 9 million.
CFO broski: We remain confident that we have sufficient funds to deliver on our milestones and get prepared to move into commercialization phase of our journey Amigo.
CFO broski: And finally, our centers before it's worth emphasizing that the May 2023, financings, where common stock only financings it.
CFO broski: It did not include any warrants on our balance sheet. As a result has a very simple straightforward capital structure with approximately 26 million shares outstanding.
Speaker Change: I'm now going to turn the call back over to <unk> for his closing thoughts.
Rick: Thanks, Rick.
Speaker Change: In conclusion. This is an exciting time for <unk> and 2044.
Speaker Change: A year in our company's evolution.
Speaker Change: I want to reiterate our FDA clearance of the AME ecosystem will be foundational for the company.
Branislav Vajdic: I'm now going to turn the call back over to Branislav for his closing thoughts. (Inaudible) So, in conclusion, this is an exciting time for Heartbeam, and 2044 is a pivotal year in our company's evolution. I want to reiterate that our FDA clearance of the Amigo system will be foundational for the company. When cleared, it will be the first patient-helped 3D-VCG device to be cleared by the FDA. It will also serve as a robust and IP-protected foundation for many future developments. As Debbie noted, we have made significant progress on the AIM-EGO clearance, having successfully passed the acceptance of the filings and completed the initial review phase. We have taken advantage of all available regulatory tools and opportunities to work interactively and intensely with the FDA.
Speaker Change: Clear it will be the first patient D D D D.
To be clear by the FDA. If you will also serve as a robust and IP protected.
Speaker Change: Foundation for many future developments.
Speaker Change: Yeah that'd be noted.
Speaker Change: Have made significant progress on the amey golf clearance, having successfully passed the acceptance of the pilot filings.
Speaker Change: <unk> completed the initial phase.
Speaker Change: Taking advantage of all available regulatory tools.
Speaker Change: Do you need to work.
Speaker Change: Actively and intensely with the FDA and we are finalizing our testing.
Speaker Change: Our formal responses to questions raised by the FDA.
Speaker Change: These responses.
Speaker Change: <unk> submitted the FDA will complete their review.
Speaker Change: We currently anticipate who units by the end of Q2 of this year.
Speaker Change: This initial clearer this is foundational for a number of reasons first it will be.
Branislav Vajdic: And we are finalizing our testing and our formal responses to questions raised by the FDA. Once these responses are submitted, the FDA will complete its review, and we currently anticipate clearance by the end of Q2 of this year. This initial clearance is foundational for a number of reasons.
Speaker Change: The basis of our second submission.
Speaker Change: Oh, the algorithm will generate leads synthesize ECG.
Speaker Change: And as we've discussed we will have.
Speaker Change: A completed.
Speaker Change: 80 patient pilot study.
Branislav Vajdic: First, it will be the basis of our second submission on the algorithm that we will generate from the synthesized ECG. And as we discussed, we will have a completed 80 patient pilot study. And once we have completed it, we have actually engaged in the pivotal study that's in progress as we speak. Second, we are developing deep learning algorithms using our 3 dB CG signals for input.
Speaker Change: And once we have completed it.
Speaker Change: We have actually engaged.
Speaker Change: In the pivotal study.
Speaker Change: In progress as we speak.
Speaker Change: Second we are developing the quoting activity.
Speaker Change: Intelligence all with us.
Speaker Change: Using our <unk> Cmos for inputs.
Speaker Change: We are very much encouraged by the progress and early results and we look forward to presenting the initial clinical data.
Branislav Vajdic: 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. [inaudible] We will build upon the initial AMIGO clearance as a foundation. With both the 12-nit synthesis algorithms and AI efforts, we will continue to advance our robust product pipeline. This includes
At safe disease meetings in Q2 of this year.
Speaker Change: Finally, we will build upon the initial Amy go clearness as a foundation.
Speaker Change: We bought the Belle Meade surfaces algorithms.
Speaker Change:
Speaker Change: We will continue to advance our robust product pipeline.
Speaker Change: This includes.
Speaker Change: AI enabled Alaska expense indications as well as patient sadly for factors such as the on demand.
Branislav Vajdic: 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. We ended 2043 ahead of plan with $16.2 million in cash, and Casek Rowens as of December of last year. We anticipate that our strong cash position provides runway to early 2045. We remain confident that we have sufficient funds to deliver on our limited launch of Amygo that is currently anticipated to occur by the end of this year. I look forward to providing our shareholders with further updates in the near term. I thank you all for attending, and now the Heartbeat team would like to answer your questions. [inaudible] Thank you. At this time, we will be conducting a question and answer session, and if you would like to ask a question, please press star 1 on your touch screen. The confirmation tone will indicate your line is in. You may press star 2 if you would like to remove your...
Speaker Change: The batch.
Speaker Change: It would be hard to watch.
Yes.
Speaker Change: We ended 2043 ahead of plan with $16 2 million in cash and.
Speaker Change: Cash equivalents as of December of last year.
Speaker Change: Anticipate this our strong cash position provides runway through early 2045.
Speaker Change: We remain confident that we have sufficient funds to deliver on our limited launch of Amy go.
Speaker Change: It is currently anticipated to occur by the end of this year.
Speaker Change: I look forward to providing our shareholders with further updates in the near term.
Speaker Change: Thank you all for attending and now hockey team would like to answer your questions.
Speaker Change: Operator.
Operator: Thank you at this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: Confirmation tone will indicate your line is in the question queue.
Operator: You May press Star two if you would like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
Operator: Participants are using speak, and maybe it's necessary to pick up. Our first question comes from the line. Ben Haynor with Alliance Global Partners.
Operator: Our first question comes from the line of Ben Hayner with Alliance Global Partners. Please proceed with your question.
Ben Haynor: Good afternoon. Good afternoon, guys. Thanks for taking the question.
Ben Haynor: Good afternoon, guys. Thanks for taking the questions. First off, for me, Debbie, I'm just curious about the official responses that you're formulating. With your FDA hat on, I guess, how would you characterize the questions that you've gotten? Are they fairly straightforward? You know, any sort of showstoppers?
Ben Haynor: First off for me.
Ben Haynor: Just curious on the official responses that youre formulating.
Ben Haynor: With your FDA had on I guess, how would you characterize the questions that <unk> gotten fairly straightforward.
Ben Haynor: Sort of show stoppers any any surprises on that front.
Ben Haynor: Yes, Debbie would you please comment on that.
Debbie Castillo: Yeah, certainly so.
Debbie Castillo: First you know there seems to be a <unk> received a number of questions. You mentioned that spend many participants so what I can share is that the current status and processed five thank you.
Debbie Castillo: Any surprises on that front? Yes, Debbie, would you please comment on that? Yeah, certainly. First of all, there seem to be a number of questions similar to this from many participants.
Debbie Castillo: The nation is within expectation.
Debbie Castillo: From my perspective and experience from being on both sides of the fence. This is a typical practice or find KKR.
Debbie Castillo: I think he reviews or FTE provides are open questions that must be answered prior to their final assessment and submission so for me.
Debbie Castillo: So, what I can share is that the current status and process of our 510k submission is within expectation. Definitely, from my perspective and experience from being on both sides of the fence, this is a typical process for 510k reviews, where FDA provides its open questions that must be answered prior to their final assessment and submission. So for me, this is a pretty standard process and sort of questions from the agency. So in doing that, to address this as best we can, as we've mentioned, we're using the regulatory tools available to industry, where we have leveraged all opportunities to engage with the agency in order to align with our responses and approach to these open questions. This will help us ensure that our responses will meet FDA expectations and, of course, then allow FDA to make their final assessment of our submission. Okay, that's helpful.
Debbie Castillo: Pretty standard process and incidents.
Debbie Castillo: Questions from the agency.
Debbie Castillo: So in doing that to address this as best we can as we've mentioned, we're using the regulatory tools available to industry, where we have leveraged opportunities to engage with the agency in order to align with our responses and approach to these open question.
Debbie Castillo: It will help us ensure that our responses will meet the expectations and of course, then allow us to make their final assessment of our submission.
Debbie Castillo: Yes.
Speaker Change: Okay. That's helpful and then.
On the on future FDA submissions for the AI applications do you have any sort of timeline on when we might.
Speaker Change: So start.
Speaker Change: Start to expect those submissions going in or is that kind of open ended at this point.
Speaker Change: Yes, as you know we have engaged in the full speed AI development technology development or not so we have made incredible progress over the last six months.
Speaker Change: And we are at this point assessing really what the schedule will be so we at this point not ready to share anything, but we are intensely in the in the phase of estimating the airport.
Branislav Vajdic: And then... On future FDA submissions for the AI applications, do you have any sort of timeline on when we might start to expect those submissions going in, or is that kind of open-ended at this point? Yes, as you know, we have engaged in full speed AI development technology development for AI. Not so long ago, we have made incredible progress over the last six months, and we are at this point assessing really what the schedule will be.
Speaker Change: To get that $5 8-K.
Speaker Change: Submit it eventually clear.
Speaker Change: Okay got it and then <unk>.
Lastly for me on commercialization kind of once you get that second Amy go.
Speaker Change: Clearance is that kind of the time to wrap up our ramp up excuse me.
Speaker Change: The commercialization bulks in and begin adding to the team again or would that be kind of later on after you make potentially some of these AI submissions.
Branislav Vajdic: So we are at this point not ready to share anything, but we are intensely in the phase of estimating the effort to get that 510k submitted eventually cleared. Okay, I got it. And then lastly, for me on commercialization, you know, kind of once you get that second Amy Goh clearance, is that kind of the time to wrap up or ramp up, excuse me, the commercialization folks and begin adding to the team again? Or would that be, you know, kind of later on after you make potentially some of these AI submissions? Rob?
Speaker Change: Yeah, I'll take that yeah, no we.
Speaker Change: As we said we're planning on doing a limited launch by the end of 2024. So we're currently.
Speaker Change: Pretty deep and work with our current team of defining the go to market strategy and our plans and as we get closer with the first clearance have the opportunity to get some beta testing and experience with the device we plan to be ramping up the commercial team.
Robert Eno: Yeah, I'll take that. Yeah, no, we, um, you know, as we said, we're planning on doing a limited launch by the end of 2024. So we're currently, you know, pretty deep in work with our current team defining the go-to-market strategy and our plans. And as we get closer to the first clearance, have the opportunity to get some beta testing and experience with the device, we plan to be ramping up the commercial team, kind of in conjunction with that with that limited launch toward the, Okay, got it. Very helpful. Congratulations on all the progress, guys, and I'll jump back in.
Speaker Change: In conjunction with that with that limited launch towards the end of the year.
Speaker Change: Okay got it very helpful. Congrats on all the progress guys ill.
I'll jump back in queue.
Speaker Change: Thank you thank you Matt.
Speaker Change: Thank you and as a reminder, if anyone has any questions. You May press star one on your telephone keypad doing so will ensure your lines join into the question and answer queue.
Speaker Change: And there are currently no questions for the.
Speaker Change: <unk>.
Speaker Change: Telephone Q&A session.
Speaker Change: Therefore, I'll now hand, the call over to Brooks Hamilton for any questions on the webcast.
Unknown Executive: Thank you operator.
Unknown Executive: First question asks could you describe the valid ECG study in more detail.
Unknown Executive: Specifically as it relates to patient follow up or endpoints.
Unknown Executive: Sure.
Operator: Thank you. Thank you, Ben. Thank you. And as a reminder, if anyone has any questions, you may press star one on your telephone keypad. Doing so will ensure your line is joined to the question. There are currently no Telephone Q&A sessions. Therefore, I'll now hand the call over to Unknown Speaker 0. Thank you, operator.
Unknown Executive: So first to reiterate the goal of this study is to demonstrate that our synthesize <unk> Sim.
Unknown Executive: Similarly, a clinically comparable to a standard hospital base 12 lead ECG and we're doing that by taking simultaneous recordings of both the 12 lead and Andy Amy go devices literally simultaneous while the patient has the electrodes from a standard 12 lead we also place the <unk> device on as.
Operator: The first question asks, Could you describe the valid ECG study in more detail, specifically as it relates to patient follow-up or endpoint? Sure. So first, to reiterate, the goal of the study is to demonstrate that our synthesized 12-lead ECG is clinically comparable to a standard hospital-based 12-lead, And we're doing that by taking simultaneous recordings of both the 12-lead and the Amigo device. They're literally simultaneous.
Unknown Executive: As far as endpoints, we've worked closely with FDA to define the endpoints. The primary endpoint is looking at a series of ECG measures that are called intervals in amplitudes.
Unknown Executive: We've also defined what the performance criteria is in other words, how similar these measurements need to be between the synthesize 12 lead in the standard 12 week. There is also a secondary endpoint, which physicians will categorize all the arrhythmias that they see them. This web leads in a blinded manner and we'll analyze the similarities and differences.
Robert Eno: While the patient has the electrodes from a standard 12-lead, we also place the Amigo device. As far as endpoints are concerned, we've worked closely with FDA to define the endpoints. The primary endpoint is looking at a series of ECG measures that are called intervals and amplitudes. We've also defined what the performance criteria is, in other words, how similar these measurements need to be between the synthesized 12-lead and the standard 12-lead.
Unknown Executive: So between the two.
Unknown Executive: As far as follow up Theres no patient follow up in the study. So there are only analyzing the simultaneous recorded ecg's during a single visit and just I think what I'd add onto that as we mentioned, we're rolling 198 patients at up to five sites. They are a leading U S research centers, but also high volume and because they're high vol.
Robert Eno: There's also a secondary endpoint, which physicians will categorize all the arrhythmias that they see. As far as follow-up, there's no patient follow-up in the study, so only analyzing the simultaneous recorded ECGs during a single visit. And, you know, just I think what I'd add on to that is we mentioned we're enrolling 198 patients at up to five sites. They're leading U.S. research centers but also high volume. And because they're high volume and these are arrhythmia clinics with lots of patients coming in every day, we expect to be able to see a range of arrhythmias, which helps us in the study. And we also expect to enroll patients quickly. And that's why we anticipated enrollment being complete in Q3. Thank you. Next question. It seems like you're developing AI tools internally, but so many of them have already been developed by academia. Why not license them?
Unknown Executive: And these are arrhythmia clinics, where there are lots of patients coming in every day, we expect to be able to see a range of a rhythm years, which helps us in the study and also <unk>.
Unknown Executive: Specced enroll patients quickly and Thats why we anticipate enrollment being complete in Q2 of this year.
Excellent. Thank you.
Speaker Change: Next question I mean, it seems like you're.
Speaker Change: Developing AI tools internally, but so many of them are already developed by academia.
Speaker Change: Got a license.
Speaker Change: Yes, we are keenly following everything that's being published and there is a lot of it in the literature. These days.
Speaker Change: Yeah.
Speaker Change: However, and lucky.
Speaker Change: Lucky for us.
Speaker Change: Our seatbelts.
Speaker Change: T D <unk>.
Speaker Change: Yeah very much data at each source.
Speaker Change: Or inputs, if you want to the AI and so for US is key.
Branislav Vajdic: Yeah, we are keenly following everything that's been published, and there is a lot of it in literature these days. And that's relevant. However, and luckily for us, our signals are 3D ECG signals, which is a very data resource or input if you want to train the AI. And so for us, it's key that we develop our AI tools and methods based on this data-rich set of X, Y, and Z signals. So that's the key differentiation.
Speaker Change: Develop our AI tools and methods.
Based on this data the septal X Y and Z Z loss, so thats, a key differentiation and of course, the single customer that device and it goes device, it's always been debated.
Speaker Change: So all in all that the key why.
Speaker Change: Following what's happening in the field, but our unique situation is that we have even though more data at each set of signals and that's why we'd like to take full advantage of those.
Branislav Vajdic: And of course, these signals come from a device, any GO device, that's always with the patient. So, all in all, that's the key reason why, you know, we are following what's happening in the field. But our unique situation is that we have even a more data-rich set of signals. And that's why we like to take full advantage of that, those sets of signals that come out of any GO device. 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 that's normally not available, you know, 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, you know, we have 30-second recordings, right, you know, and all So having 30-second recordings will make a positive impact on accuracy as well.
Speaker Change: Those sets of Cmos would come out of Amy go device secondly.
Speaker Change: Based on the fact that this technology will be with the patient quality four seven and very many ECG there'll be taken by the patient and users over time.
Speaker Change: This longitudinal data.
Speaker Change: This is normally not the vehicle.
Speaker Change: Hospital ETP environment.
Speaker Change: He is an extremely important source of differential signals.
Speaker Change: We really can't comprehend.
Speaker Change: Additional light on the disposition of that patient.
Speaker Change: And lastly, we have 30 seconds reporting side.
Speaker Change: And all of these.
Speaker Change: Tools that you see published results given.
Speaker Change: Second quarter.
Speaker Change: So Kevin 30 seconds reporting.
Speaker Change: Ill make a positive impact of the accuracy as well so all in all.
In summary, we are following but our unique situation.
<unk>.
Speaker Change: Set of Cmos et cetera features that go beyond what everybody else has so that's the main reason why we have developed.
Branislav Vajdic: 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 internal link, which, on the other hand, we plan 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 engaged one of them because they have many, many more signals. And secondly, you know, in some of the areas of prediction, they might be well ahead of everybody else.
Kevin: Yes on the other hand, we would be.
Kevin: B plant.
Kevin: Julie to engage some of these academic institutions in the future for some of the predictive algorithms perhaps.
Kevin: And so I wouldn't be.
Kevin: Yes.
Kevin: <unk> actually.
Kevin: Engage lots of them because they have many many more signals.
Kevin: Secondly in some of the areas of prediction there might be well ahead of everybody else.
Speaker Change: Thank you.
Speaker Change: The next question is where will the Amy go device be manufactured.
Branislav Vajdic: Thank you. The next question is, where will the Amigo device be manufactured? Yeah, this is Rick.
Speaker Change: Okay.
Speaker Change: Take care of that.
Speaker Change: <unk> you want to do that.
Speaker Change: So in Arizona.
Richard D. Brounstein: I'm happy to take care of that. Branislav, do you want to do it? So it is... All right, fine. 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 have links in with a group called Evolve Manufacturing. All of those are discussed in the 10K, and Evolve will do the initial manufacturing, with the quality systems interlinked. 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 stages, we will, you know, we can probably make 10,000 a month or so. So I think it'll get us going for some period of time.
Speaker Change: Alright sure. So thank you so the.
Speaker Change: We've been working in Silicon Valley with Triple ring, what's been helping us on the development of the hardware and they link camera with a group called evolved manufacturing.
Speaker Change: All of those are discussed in our 10-K and evolve we'll do the initial manufacturing quality systems Interlink, we are looking forward to an easy transition.
Speaker Change: Ultimately when we get into higher volumes.
Speaker Change: We'll likely be moving outside but in the initial.
Speaker Change: We will.
Speaker Change: We can probably make 10000 amongst ourselves so I think it'll get us going for some period of time.
Speaker Change: Great. Thank you.
Speaker Change: Next question are you able to deal with cyber security aspects that the FDA and the FCC are very much focused on that.
Debbie Castillo: Debbie please.
Debbie Castillo: Sure I can take that so certainly cyber security is clearly an important area for FTA, but also for our team as we strive to keep our systems secure to that and our internal team in conjunction with working with cyber security experts in the field. They feel confident that we are able to meet all regulatory expectations.
Richard D. Brounstein: Thank you. Our next question: are you able to deal with cyber security aspects, as I hear that the FDA and the SEC are very much focused on this? Debbie, please.
Debbie Castillo: Sure, I can take that. So certainly, cybersecurity is clearly an important area for FDA, but also for Heartbeam, as we strive to keep our systems secure. To that end, our internal teams, in conjunction with working with cybersecurity experts in the field, feel confident that we are able to meet all regulatory expectations, both from the FDA and the FCC side. I'll also point out that we've included our cybersecurity policy, which is disclosed in the 10-K for additional information. Thank you. Next question.
Debbie Castillo: Both from the FDA and the FCC side.
Debbie Castillo: I also point out that we've we've included our cyber security policy and in which is disclosed in the 10-K for additional information.
Okay. Thank you.
Speaker Change: Next question.
Speaker Change: Medical studies are usually very expensive and did you fully account for the cost of your valid ECG study within your final financial projections.
Speaker Change: Back to the cost of of this study.
Speaker Change: Hey, good luck again.
Speaker Change: It actually is not so extensive as people might believe there is no intervention required there is no follow up required. So it is much less expensive, we've actually signed contracts with our clinical research organization.
Unknown Executive: Medical studies are usually very expensive. Did you fully account for the cost of your valid ECG study within your financial projections? Can you speak to the cost of the study? It actually is not as expensive as people might believe. There is no intervention required, and there's no follow-up required, so it is much less expensive.
Speaker Change: And the first of our expected five sites.
Speaker Change: In the footnotes in the financials that 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 dollars and the cost of the enrolling.
Richard D. Brounstein: 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 half a million, and the cost of enrolling the approximate 200 patients, 198 were, is going to be about $200,000. So the full cost of the study is going to be about $700,000.
Speaker Change: Approximately 200 patients 198 were predicting there's going to be about 200000. So the full cost of the study is going to be about 700000.
Speaker Change: Yes.
Speaker Change: Thank you there are no more questions at this time, so I'd like to now turn.
Speaker Change: Turn the call back over to Dr. <unk> for his closing remarks.
Dr. unknown: Yes, thank you operator.
Dr. <unk>: I'd 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 grow.
Branislav Vajdic: 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. Yeah, thank you, operator. I would like to thank each of you for joining our 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. This concludes today's conference and you may disconnect your line at this time. Thank you for your patience. [inaudible] ?? ?? ?? ?? ?? ?? ?? ?? ?? ??
Speaker Change: 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.
Speaker Change: And this concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.
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