Q1 2025 HeartBeam Inc Earnings Call
Speaker Change: Greetings and welcome to the Heartbeam First Quarter 2025 Financial Results Conference call.
Speaker Change: 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 call is being recorded.
Speaker Change: 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.
Speaker Change: While these forward-looking statements represent our current judgement on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ
Speaker Change: You are cautioned not to place undue reliance on these forward-looking statements which reflect our opinions only as of the date of firm presentation.
Speaker Change: Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision of these forward looking statements in light of new information of future events.
Speaker Change: Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions.
Speaker Change: You should also review our most recent Form 10K and Form 10Q for a more complete discussion of these factors and other risks particularly under the heading risk factors.
Speaker Change: A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company's website heartbeam.com
Speaker Change: Your host today, Rob Eno, Chief Executive Officer, and Tim Cruickshank, Chief Financial Officer, will present results of operations for the first quarter ended March 31st, 2025.
Speaker Change: At this time I will turn the call over to Heartbeam Chief Executive Officer Mr. Rob Eno.
Thank you for watching.
Speaker Change: Thank you, operator. The topics we'll cover on today's call are listed on the slide. We'll provide a brief reminder of the Heartbeam System and its status, followed by our progress to 2025 milestones.
Speaker Change: We'll then provide more details on the Valid ECG data and the recently announced collaboration with AccuCardia. Next, we'll touch on our commercial readiness efforts and our long-term vision, followed by financial results before turning it over to Q&A.
Speaker Change: Before we dive into updates from the last quarter, I wanted to remind everyone about our initial product, the Heartbeam System.
Speaker Change: Heartbeam is developing the first-ever personal, capable-free ECG that can synthesize a 12-lead ECG.
Speaker Change: Our unique IP protected approach captures the heart's electrical signals in three dimensions or three non-cold planar directions. Site to side, top to bottom and into the body.
Speaker Change: We believe bringing this 12-lead capability directly into the hands of patients is extremely disruptive to how cardiac conditions are currently managed. The system is designed to be easy to carry and easy for patients to use wherever and whenever they have symptoms.
Speaker Change: We also believe this has the potential to be the highest resolution Amplatory ECG monitor, and that adding artificial intelligence to these high resolution signals acquired by patients will longitudinally over time can result in unsurpassed algorithms providing personalized cardiac insights.
Speaker Change: In December of last year we received our foundational FDA 510K clearance. This is for the system as a whole for a RISME assessment, the credit card signal collection device, the patient application of physician portal and signal quality algorithms.
Speaker Change: The system outputs three ECG waveforms representing the three non-co planar directions captured by our technology.
Speaker Change: In January , we submitted our second FDA 510K application. This is for the software that synthesizes a 12-lead ECG from our 3D signals for a RISME assessment. This is important because it takes the high-resolution signals collected by the Heartbeam system and synthesizes them into a familiar 12-lead ECG, something that physicians are used to reviewing on a daily basis.
Speaker Change: This application is currently being reviewed by the FDA. We continue to expect clearance for the software by the end of the year. These two clearances together will form the product with which we'll start our initial commercialization.
Speaker Change: We've achieved a number of important milestones since our last call. At the heart rhythm society meeting last month, Dr. Tom Gearing from the Piedmont Heart Institute presented the result of our Valid ECG study. He announced that we met the end point for the study, which formed the basis of our FDA submission for the 12-lead synthesis software for arrhythmia
We've also made progress on the regulatory front.
Speaker Change: We're in positive and productive discussions with the FDA on the 12 lead synthesis software submission. We're in the substantive review portion of the process, and we continue to anticipate clearance by the end of the year.
Speaker Change: FDA staff have been very engaged and responsive and we have not experienced any delays or issues related to the recent events of the FDA.
Speaker Change: In addition, we started our interactions with the FDA on expanding our indication to include ischemia, which is inadequate blood flow to the heart. ECGs can detect electrical changes that occur during a Schema event such as heart attacks. We're engaging with the FDA to discuss our rationale and critical study plans.
Speaker Change: While we make progress with the FDA on the regulatory side, we're executing on our plans to become commercial ready. We're working to have the processes and systems in place to launch commercially after receiving FDA clearance on the 12 lead synthesis software.
Speaker Change: The collaboration we recently announced with Acucardia will add to our commercial efforts and we'll describe that collaboration in more detail today.
Speaker Change: Other recent developments include two new issued U.S. patents, bringing the total to 20 issue patents worldwide. Intellectual property is very important to Heartbeam and will continue to invest in protecting our unique technology.
Speaker Change: Also, I was appointed to the board of directors. I'm excited to join the board and to continue to work closely with our existing board members as we drive toward commercialization of the Heartbeam System.
Speaker Change: Another expansion was to the membership of our Scientific Advisory Board, adding Dr. Vivek Reddy from Mount Sinai. Dr. Reddy is a world-leading electrophysiologist and his appointment further enhances this group of preeminent cardiology advisors, both in interventional cardiology and electrophysiology.
Speaker Change: At our call in November , we laid out this framework, demonstrating the key milestones for the end of 2024 in all of 2025. I'm pleased to say that we continue to make great progress in achieving these milestones.
Speaker Change: The three milestones in the circle are the ones we achieved since the call two months ago, announcing a strategic collaboration with Akikardia on the arrhythmia classification algorithm, initiating discussions with the FDA on our ischemia indication and the presentation of the Valid ECG data.
Speaker Change: On the arrhythmia classifications, I mentioned on the last call that we made a decision to prioritize a collaboration for the arrhythmia detection algorithm pivoting from the earlier plan of conducting a clinical study on the algorithm that we developed internally.
Speaker Change: We anticipate that the collaboration will result in significant savings both in time and money. I'll describe the acochardia collaboration in more detail in a minute.
Speaker Change: On the Aschemia Indication, we have strong proof of concept data on our systems ability to detect ECG changes that are related to heart attacks and other acute coronary changes. We're excited to be engaging with the FDA to determine the regulatory and clinical plan to expand into this new indication.
Speaker Change: We continue to anticipate that later this year, we'll initiate a pilot clinical study on the use of our system and patients with the Schemia.
Speaker Change: On the Validys, he cheated in the results of the Pivotal Study were presented last month at the Heart Rhythm Society, and I'll provide more details on the next slide.
Speaker Change: Before moving on, I wanted to add that one of the main objectives that Tim and I had when we started our new positions late last year was communicating and then executing on these important milestones.
Speaker Change: Since creating this list and showing it at the earnings call in November , the team has done an exceptional job to achieve the milestones we said we're going to achieve.
Speaker Change: The main focus for the company for the remainder of 2025 is working with FDA on the review of our 510K application and on our commercial readiness efforts, completing these milestones and put us in a great position for a successful commercial launch.
Speaker Change: Next, I'd like to spend a little time providing more details on two of the reads and milestones, the Valid ECG study and the Acure Cardiac Collaboration, as well as on our commercial readiness efforts.
Speaker Change: I wanted to dive deeper into the clinical results of the Valid ECG Pivotal Study, which formed the basis of our submission to the FDA on the 12-lead synthesis software for arrhythmia assessment. Dr. Tom Deering from Piedmont Heart Institute, Nidilana, and the former President of the
Speaker Change: The study enrolled 198 patients at 5 U.S. Centers. These patients were in arrhythmia clinics, included patients with sinus rhythm and a variety of arrhythmias.
Speaker Change: They had simultaneously recorded standard 12 lead ECGs in our device. Our system then synthesized the 12 lead ECG from our signals and these were compared to the standard 12 lead ECGs.
Speaker Change: The Heartbeam system is designed to be used by patients at home, so this is a very important study to determine how similar our synthesized 12 lead ECGs are compared to what standard 12 lead ECGs for a RISME assessment.
Speaker Change: The study compared the ECG signals quantitatively. You can see an example from one of the patients here and how similar the waveforms are.
Speaker Change: The study looked at a series of ECG intervals. Those are the time between different points of the signals and amplitudes. That's the height of specific points of the signals. We reported mean differences between the standard 12 lead ECGs and our synthesized 12 lead ECGs for several intervals and amplitudes. We reported mean differences between the standard 12 lead ECGs for several intervals and amplitudes.
Speaker Change: For each of these, the differences were less than the margin of error you would normally see when a person measures an ECG. As you can see on the graph, the standard ECG papers made up of large boxes and small boxes.
Speaker Change: The difference is between the synthesized and standard 12 EDCGs in the study were tiny, all less than one fifth of the size of a small box.
Speaker Change: In addition, physicians reviewed all of the ECGs and classified them as normal sinus rhythm or one of the series of arrhythmias.
Speaker Change: The physicians looked at the ECGs independently and in a blinded manner. A total of 93.4% of the time, the classification was the same between the standard 12 lead and the heartbeam 12 lead. This is a high level of agreement, similar to what you would expect when two physicians review the same ECG.
Speaker Change: So in short, the goal of the study was to demonstrate four physicians and for the FDA that synthesized 12 lead ECGs produced from RECG taken by patients closely approximate the signals from a standard 12 lead ECG for RIDME assessment. The study met these performance goals.
Speaker Change: Thank you to Dr. Gearing and all the investigators, collaborators and the patients in the study for helping us achieve this very positive result.
Speaker Change: Next, we're very excited to have recently announced a strategic collaboration with AccuCardia. Based in New York, AccuCardia is an ECG-led diagnostics software company. They're developing a suite of ECG algorithms, both classification and detection algorithms.
Speaker Change: The collaboration is focused on adding to the Heartbeam system AcchaCardi is FDA-Cleared Acure ECG algorithm, which automatically classifies the rhythm from the ECG signals.
Speaker Change: However, we want to encourage our users to take as many readings as they like to practice and to build up their data. Over time, the patient's prescribing physician can review the ECGs and notice any underlying
Speaker Change: For this asymptomatic use case, we'd like our patients to receive an automated assessment of the rhythm. This is where active cardio's accurate ECG comes in.
Speaker Change: We've reported previously that Heartbeam has developed a deep learning-based algorithm to classify [inaudible]
Speaker Change: We're excited that we can combine AccuCardi's FDA-Cleared Solution with the FDA-Cleared Heartbeam Solution. We're currently working with AccuCardi to determine the steps to clear this joint solution and we'll have more details in an upcoming call.
Speaker Change: In addition, the agreement with Akikardia has an economic framework that will be finalizing as we move to the commercial stage. At a high level, there's no upfront payment, but we will be paying a reasonable per user fee for integrating their algorithm.
Speaker Change: Finally, while the scope of the collaboration is currently limited to the Accure ECG algorithm, Accure Cartier has an exciting pipeline of technology and there's a potential for expanded collaborations in the future.
Speaker Change: The two major efforts for Heartbeam this year are securing the FDA clearance for a 12-lead synthesis software and undertaking the necessary steps to become commercial ready in advance of our commercial launch, which is expected by the end of the year.
Speaker Change: We've started our early access program in which we're testing the product with concierge accounts and patience. This program is giving us incredibly valuable feedback on all aspects of our offering, including the onboarding workflow and physician and patient training while generating additional data on real world use of the heartbeam system.
Speaker Change: Other aspects of commercial readiness that are underway include building out the infrastructure to support the end-to-end workflow from the physician's office to the patient's home and implementing the customer support function.
Speaker Change: We're also establishing inventory and logistics support and have selected a contract manufacturer. All of which will allow us to scale the business.
Speaker Change: Meanwhile, we're developing a comprehensive launch plan and we'll share more details as launch approaches.
Speaker Change: In summary, our preparations for initial commercial launch are progressing well. Before Tim discusses the financials, I wanted to step back and articulate what we see as the value we're creating here at Heartbeam.
Speaker Change: Everything starts with our strong IP position. We now have 20 issued patents worldwide.
Speaker Change: The core of the technology enables us to create the smallest, easy-to-use, and first capable free ECG device that synthesizes a 12-lead ECG.
Speaker Change: We've significantly de-risked the business through our foundational FDA clearance and significant clinical data showing similarity to a standard 12-lead ECG for a RISME assessment.
Speaker Change: Next, the upcoming market introduction holds significant promise. As we described previously our target market segment of patients who are members of concierge in preventive cardiology practices is a $500 million serviceable market in the US with a high margin recurring revenue model.
Speaker Change: Market Research indicates that there's extremely strong demand for our target patients and physicians. We believe the concept is compelling and it's resonating, the unique combination of a cable-free ECG that produces a 12-lead, read by cardiologist.
Speaker Change: We're exploring a number of wraparound features and services to add additional value and to drive adoption and stickiness.
Speaker Change: Beyond our initial indication of arrhythmia, the potential to expand into ischemia and heart attack detection opens up a huge opportunity. The coronary artery disease market is larger than the atrial fibrillation market, with 20 million patients in the US who have had a prior heart attack, or who are at elevated risk for one.
Speaker Change: We intend to demonstrate our system's ability to reduce the time from the onset of symptoms to the emergency room door. A technology that achieves this will have dramatic clinical and healthcare economic benefits and a potential for significant payment by the healthcare system.
Speaker Change: And that ties to our next area. There are a number of ways which we can expand beyond patient pay and have our technology paid for by the healthcare system.
Speaker Change: As we discussed in our last call, there are new category 3 CPT codes that have the potential to cover our technology.
Speaker Change: In addition, there are several clinical use cases in which high-risk patients can benefit from having an easy-to-use 12-lead ECG with them at home to drive more proactive and less expensive care.
Speaker Change: Finally, one of the most exciting elements of our technology is the breadth of our opportunities that the core technology can address. First, predictive algorithms on 12 lead ECGs can screen for or even predict the likelihood of developing variety of medical conditions. Applying these algorithms could allow heartbeam users to have valuable and proactive information about their heart health.
Speaker Change: Training algorithms on longitudinal data taken with the heartbeam system could allow for trending data that has not been possible.
Speaker Change: Heartbeam has issued patents on additional form factors, an on-demand 12-lead patch could be a best-in-class offering in the multi-billion-dollar extended wearer patch market, incorporating Heartbeam's technology into a watch form factor would seamlessly integrate with continuous monitors in a single device.
Speaker Change: In all, we're excited about Heartbeam's IP protection, de-risking and the immediate market opportunity, but we also see it as an open-ended opportunity with the ability to make a dramatic impact on a large number of patients and change the way that cardiac care is managed.
Speaker Change: So now, let's turn it over to Tim to walk through the financials.
Tim Cruickshank: Thanks Rob, great updates. Our focus on cash management is directly in line with these updates Rob gave. We've got strong financial discipline in place as we continue to de-risk the business and execute on near-term milestones.
Tim Cruickshank: and we'll make the properly timed investments into commercial readiness to be prepared so long, so on the back of this upcoming FDA clearance, all the while managing to keep an eye out on the future and opportunities for strategic collaborations for our technology.
Tim Cruickshank: Our Q1 cash flow is indicative of this approach. We had net cash use and operating activities of 4.5 million for the quarter.
Tim Cruickshank: But let's dive into that number within that span, 3.6 million related to the recurring baseline expenditure. This is predominantly our R&G span for clinical regulatory and product development initiatives and GNA directly aligned with our stated milestones.
Tim Cruickshank: In addition to that, to the baseline spend, we invested 400,000 in the quarter into commercial readiness activities and manufacturing capabilities related to launch.
Tim Cruickshank: Rob took you through a number of those initiatives on a previous slide which included testing with county areas accounts and patients in the early access program as well as onboarding a contract manufacturer designed for scale.
Tim Cruickshank: So we're very confident in our investments at their well times and that they'll lead to tremendous gains for the company in time.
Tim Cruickshank: The remaining spend of $500,000 was for one offer annual payments associated with Q1 to
Tim Cruickshank: and included in that where employee expenses related to a handful of roles will be eliminated during the quarter. I mentioned this just to point out that even with an already lean organization, we continue to make the necessary decisions in the best interest.
Tim Cruickshank: the company and shareholders to ensure spend is aligned with our primary objectives and our timeline for achieving milestones.
Tim Cruickshank: The deep prioritization of a few long-term initiatives, we were able to reduce...
Tim Cruickshank: are recurring spend slightly. So, to give some context, the one specific example would be the Raised MCG study for arrhythmia classifications that route to Keturu. We were able to construct the alternative plan of licensing and algorithm versus conducting the full blown clinical trial this year.
Tim Cruickshank: and in going this other route, we were able to eliminate the cost of the trial and some of the resources previously assigned to this area.
Tim Cruickshank: As I stated last quarter, baseline for 2025, the spend last year was 14.5 million for operating activities in 2024.
Tim Cruickshank: That's a good baseline for this year and on top of that will be some well times expenditure on commercial readiness activities that spend ranges from 1.5 to 3.5 million in 2025, depending on the number of factors, including the timing of when we bring those things on.
Tim Cruickshank: We accomplished a lot with a relatively modest investment this past quarter of 400,000 and will continue to be prudent and timing moving forward So to summarize we've got a we've got strong financial discipline in place as we continue to de-risk the business, but also as we look to make timely investments into commercial readiness.
Tim Cruickshank: Also note of note during the quarter, we completed the 11.5 million common stock public offering.
Tim Cruickshank: with MDB Capital, and we'll continue to strategically fund the company as we execute on milestones all the while managing dilutions, dilutions, excuse me, we're really excited about the progress we've made so far this year and the road ahead.
Tim Cruickshank: We're confident we're putting ourselves in a great position for inflection points throughout this year and that we have the partners and pieces in place to strategically capitalize the business as we prepare for commercialization. So we're looking forward to updating you more along the way and executing on upcoming milestones.
Rob, back over to you
Thanks Tim.
Tim Cruickshank: So in summary, we've made significant progress in the two months since our last call. On the clinical and regulatory front, the results and the valid ECG study were presented, and the study successfully met the clinical endpoints for arrhythmia assessment.
Tim Cruickshank: The study is the basis of the FDA's submission on the 12 lead synthesis software. We're in positive and productive discussions with the FDA on the 12 lead synthesis software submission.
Tim Cruickshank: We continue to anticipate clear before the end of the year. We also began engaging with the FDA on expansion of our indication into a Schemia and we expect to start a pilot study
Tim Cruickshank: We're making solid progress with our Early Access program and in setting up our internal systems and processes. We also signed a strategic collaboration with Akikardia, which will provide an important enhancement for our commercial product.
Tim Cruickshank: The main corporate priorities for 2025 remain unchanged, working with the FDA and our 12 leads, said this is submission and preparing for commercialization. We will continue to report on progress toward these two priorities.
Speaker Change: As Tim mentioned, we raised 11.5 million earlier this year and are managing spending closely as we approach commercialization we will continue to strategically fund the company in line with our near term milestones.
Speaker Change: I'm impressed with the amazing job our employees are doing and the team's dedication and success in hitting the milestones we previously described. I would forward to continuing to update you as we make additional progress in the coming quarters. We thank you all for attending and now would like to open up to Q&A. Operator?
Speaker Change: Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you were using a speaker phone, please pick up your handset before pressing the keys.
Speaker Change: If at any time your question has been addressed and you would like to withdraw your question please press star then two.
Speaker Change: The first question comes from Bill Sutherland with the benchmark company. Please go ahead.
Thanks operator.
Hayrob and Tim, congrats on all the progress.
Speaker Change: I wanted to, Rob, could you give us a little more color on kind of the input, what you learned in the Early Access Program?
this currently, I guess, and last quarter, just some of the information that's helping you understand the commercial opportunity.
Sure. I think the first thing is
Speaker Change: as I mentioned, the customer service and customer support will start to learn from, as we spin those up, learn to how those work and the details of those things in practice. So I hope that helps.
Speaker Change: Are you, is it too early to kind of think about how pricing may, may develop?
as you go commercial.
Speaker Change: Yeah, I think it's, you know, we've we've done a fair amount of market research, which is good on this and it's
You know, resonating with what we've said before, which is
You know, we believe it's, you know, likely somewhere between, you know, call it $50 to $100 per month on a recurring revenue basis. If you include the device as well as the ongoing service.
Speaker Change: What we're also exploring lots of different things in terms of pricing levels, you know, we think we might have, you know, tears where a higher tear gets you things like more cardiologist reads per time period, et cetera. So, we're going to get a lot more detail as we get closer, but that's kind of the general direction. Tim, I don't know if anything else you want to add on that. [inaudible]
No, I think that's really helpful, the um...
Speaker Change: The pricing will have optionality in terms of bundled versus upfront, but we're expecting most of it to be within the range of $50 to $100 that Rob gave from a bundled perspective based on the data we have so far. Got it Tim, while you're on what.
Speaker Change: How do we think about the timing of building out the commercial infrastructure as well as you can kind of chew it at this point?
Speaker Change: You know, we're going to start with two specific markets. They have about 45,000 patients.
Speaker Change: between the two markets. We believe we can cover that with the sales.
Speaker Change: Two sales reps and two, I'll call them clinical specialists in terms of onboarding of patients.
and I'm training the trainers.
Speaker Change: and so that relatively modest cost of a few hundred thousand dollars.
between the-
Speaker Change: Each of those geographies to kind of get them onboarded on an annualized basis covers about 45,000 patients in the early days. What we plan to do is continue to gain learnings from those two markets and as we get data that tells us to invest, we'll start to look to.
Additional Markets
in the US.
practices the
Sorry, Rob, the...
Speaker Change: I forgot the term for the concierge practices that are more nationwide. And so the third wave will be going after that more. Change, change, change of country practices.
So the first stage could be Tim, the first stage.
Speaker Change: The two target markets could be as soon as with quarter.
Speaker Change: on the backside of the FDA clearance, which at this point we have in the second half of the year in Q4, so we begin commercializing at the end of the year with really Q1 of 26 being when you start to see.
Start to see it really come on.
Okay.
Great.
Great.
Speaker Change: Bill, let me just, that's, that's a great overview. I'll just add quickly that, you know, what we've been doing now is a lot of work on, you know, free commercialization, our head of product, Richa is amazing and does kind of covers that area as well. And we have it's consultants, etc. The first thing we'll do with the appropriate time, you know, timing it as Tim said to the expenditure is bringing on a person to lead the sales effort. And then that person will help us finalize the plan.
Speaker Change: and including the initial sales folks to cover those two regions, which will kick off once we, as I say, once we get the FDA clearance and finish our commercial readiness is when we start that commercialization in those two initial markets to prove the concept.
Speaker Change: Right. Okay. Well, let me jump back in here and let other people ask questions. Thanks, guys.
Thank you.
Speaker Change: Again, if you have a question, please press star then one.
Thank you. Thank you.
Leo Caprio: The next question comes from Leo Caprio with Joseph Gunner. Please go ahead.
William Sutherland, Larry Holub, Leo Carpio
Speaker Change: Oh, good afternoon gentlemen. I have two quick questions. First, have you been able to have any updates in conversation with the FDA in terms of where the process is going for the approval and have you seen any disruption from the FDA in terms of given the whole staff attrition they've had lately? And I'll have a follow-up question.
Speaker Change: Great. I'll take that. So first on the disruption, the good news is we haven't seen any. We haven't seen, you know, and just speaking obviously from our experience with our group and our team, we really haven't seen any disruption or any delays related to things that have happened at FDA. They continue to be very engaged and very responsive to us and hitting all of the deadlines. So that's great. As far as the other question, you know, all I can say is we continue to
Speaker Change: engaged in productive discussions with them. I believe through Debbie Castillo runs our regulatory effort. We've got great relationships with FDA and really trying to be as collaborative as possible with them. So we're in what's called a substantive review phase. We're going back and forth in terms of questions, et cetera. I can't give any more clarity beyond what we said, which is, you know, we believe things are still on track for us.
Speaker Change: What we've said, which is clearance by the end of the year, we obviously keep the post of this things are going but but we continue to be encouraged by all the interactions.
Speaker Change: Okay, and then the second follow-up question is regarding your occuredia.
Speaker Change: Partnership. How does that foster your competitive position against other other potential competitors or the technologies and space and does it make your proposition a bit more palatable toward the end markets that you're trying to address?
Speaker Change: Yeah, it definitely does. You know, like I mentioned in the
in the earlier in the call.
Speaker Change: I think of it in terms of workflow and I think one of our
Speaker Change: their data. So, having this [inaudible]
Speaker Change: Automated Assessment is really important. Without that we believe there's a bit of a hole in the product where either we'd have to have everything go to the reader service or they don't get a response back. So we think it's a key part of the competitive offering to make sure that we can provide for these routine recordings and automated assessment of basic rhythms. And then actually we get they get that every time they do it, whether it's asymptomatic or symptomatic, and then the symptomatic ones also get read by a cardiologist. So in a sense,
Deeper in the Future
Perfect. Thank you.
To ask a question, you may press star, then one.
Speaker Change: As we have no audio questions at the moment, I would like to turn the call over to Larry Halle for any web questions.
Thank you for watching. Transcription by ESO.
Speaker Change: Our first webcast question asks, congratulations on the results of the Pivotal Study. You've stated the study was the basis for your FDA submission, so can you expand and you take the ways from this study and what it means for clearance?
Sure.
Speaker Change: Well, thank you, first of all, you know, the goal of the study was to demonstrate that our synthesized 12 lead ECG, that that's similar to a standard 12 lead ECG, and we did that as I mentioned through simultaneously gathered ECGs, and as I said, the study met the clinical employees, and I think they're the key.
The reason why this is important is...
Speaker Change: 12 lead ECGs of the standard, generally done in a healthcare setting with a healthcare practitioner, you know, placing the ECG in our systems designed to be used by patients outside of a healthcare facility. So, whenever they're feeling arrhythmia symptoms, they can take the reading at home instead of having to go in and have it taken by a professional. So, we have the core system cleared and we're working with FDA on the 12...
Speaker Change: lead synthesis software clearance, and this study supports that application because it shows the similarity between the ECGs. So the point is if we can demonstrate that our synthesized 12 leads are very similar to a standard 12 lead, we think that really bolsters the case for FDA and also for physicians in terms of acceptance of our product.
Thank you. Thank you.
Our next and last webcast question asks.
Speaker Change: What are your manufacturing capabilities and what is your exposure to tariffs?
Great. Happy to take that one, Rob.
Speaker Change: We mentioned on the call we signed contract manufacturer this quarter for scaling and we're also excited that these questions are becoming more relevant to us as we become commercial ready as we get through this year. So a bunch of updates on this front. In addition to mentioning the tariffs, I'll give an update on our manufacturing capabilities.
Speaker Change: So, our contract manufacturer is going to be manufacturing devices and doing final assembly at the U.S. Facilities, at their U.S. Facilities, it's a U.S.-based approach for this initial launch, which should help shield us from direct tariff impacts.
Speaker Change: Right now, U.S.-based components represent the majority of our parts, with a portion sourced from Europe , Japan, Taiwan, less than 1% right now of our parts are sourced from China
Speaker Change: Other areas related to manufacturing were actively monitoring, I'd say parts shortages and long lead time components, obviously a very fluid environment, but our team and our contract manufacturer have a great handle on procurement.
Speaker Change: There's two components we're aware of right now that we're strategizing on that will likely make advance purchases on, but we're talking about a cost in the order of around $20,000 for those two parts to stay ahead of the issue. So continues to be very manageable at present, but we obviously keep a keep an open eye on this.
Speaker Change: Our current anticipated throughput is in the thousands of devices per month which I mentioned earlier and we have the ability to duplicate and stand up production lines at a reasonable cost. So as we stand today we're in a really good position to ramp up on a manufacturing capability. Thank you very much.
Speaker Change: Perspective and will continue to monitor componentry lead times and availability as the time comes.
That concludes our webcast, Q and A.
For more information, visit www.fema.gov
Thank you. This concludes our question and answer session.
Speaker Change: I would like to turn the conference back over to Rob Eno, Chief Executive Officer for any closing remarks.
Speaker Change: Thank you, operator. Just like to thank each of you for joining the earnings conference call today. We look forward to continuing to update you on our ongoing progress and growth. And if we weren't able to answer any of your questions today, please reach out to our IRFirmMZ group who would be more than happy to assist. Thanks.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.