Greetings, and welcome to the HeartBeam Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates or other information that might be considered forward-looking.

While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions.

You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com.

Your host today, Rob Eno, Chief Executive Officer; Branislav Vajdic, President and Founder; Tim Cruickshank, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2024. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Mr. Rob Eno..

Thank you, operator. The topics we'll cover on today's call are listed on the slide. I'll provide a brief overview of the company's vision and then quickly get into providing an update on the status of our FDA submission, which is top of mind for everyone.

We'll then walk you through our management and company updates, financial results and upcoming milestones before turning it over to Q&A. HeartBeam has developed core technology that enables a new paradigm in cardiac care. HeartBeam's developed the first ever cable-free 12-lead ECG that patients can use wherever they are.

We do this by using a vector-based approach, capturing the heart's electrical signals from three dimensions and then synthesizing a 12-lead ECG. This allows users to capture the highest resolution data possible in a patient carried device, far greater than with existing wearables.

On top of this, applying AI algorithms to this high-resolution data opens up a world of possibilities, driving personalized insights. We believe that there are multiple large markets where our technology is applicable. And together, these addressable markets are worth more than $100 billion per year in the U.S. alone.

HeartBeam is well positioned to disrupt these markets with a strategy that starts with symptom-driven diagnosis moves to monitoring and screening and ultimately to replacing traditional 12-lead ECGs in hospitals and beyond as a new standard of care. In an upcoming slide, we'll provide you with an update on our FDA submission.

We believe this clearance is a foundational clearance for our technology and opens multiple product paths. Over the past few months, we've put significant effort into further refining our go-to-market strategy. Our initial plan is focused on direct patient pay, targeting concierge and preventive cardiology practices.

Beyond this, we'll gather evidence of the clinical and cost effectiveness benefits of our system in specific use cases, which we believe will be the basis for payment by insurers, hospitals and integrated delivery networks. There are three fundamental advances which form the core of our IP and enable our approach.

First, we use a vector-based approach. Vector cardiography has been an alternative to 12-lead ECG for decades. It captures the heart's electrical signals from three axis, X, Y and Z. Ambulatory ECG devices that are available today do not use this vector approach. Next, we're able to capture the three dimensions through a novel and protected way.

Two chest electrodes capture the vertical axis, two finger electrodes capture the horizontal dimension and the key invention is a novel resistive network that captures the Z-axis into the body. And finally, we take the 3D vector signals and synthesize the 12-lead ECG. There are established ways to make this conversion, but they're population-based.

In order to create an even more accurate 12-lead ECG, we use a personalized transformation matrix. When the patient is onboarded, we take a single 12-lead ECG and combine this with a HeartBeam reading. This creates the patient's personalized transformation matrix, which is saved and used going forward.

These three fundamental advances enable the breakthrough application, and we have a total of 17 issued patents worldwide. Now let's get into our update on our FDA submission. Our 510(k) submission continues to progress through active review by the FDA.

Since our last update, we've responded to the questions asked by the FDA and are working through clarifications. We continue to be confident in the FDA clearance. The FDA is engaged and fully responsive, and we continue to work interactively with them.

While we can't predict timelines or results related to FDA submissions, we remain optimistic that we will achieve our foundational FDA clearance, and we will update the market as soon as it's achieved. Over the past quarter, we've evolved our management team as we prepare for commercialization.

I'm honored to leave the organization at such a pivotal time. My career over the past 30 years has focused on creating go-to-market strategies for multiple breakthrough products. The HeartBeam technology is truly transformative and will have a huge impact on how cardiac care is managed.

I look forward to leveraging my commercial expertise to ensure the company is set up for success. I'm also thrilled to partner with Tim Cruickshank as our new CFO. He brings an incredible wealth of knowledge to growing businesses with disruptive technologies, and I know we'll benefit from that.

Additionally, I look forward to working with Lance Myers, who will leverage his prior experience from Google to guide the company and how we apply AI to our core technology. Of course, none of this would have been possible without our founder, Branislav Vajdic.

His vision and drive to change how cardiac care is managed is what got the company to this point, and I look forward to my continued partnership with Branislav, who will play an integral role in our success going forward. Now I'd like to pass it over to Branislav, who wants to add a few words..

Thanks, Rob. Since we started working together, Rob and I have always had a great synergy, and I knew he would be the right leader for HeartBeam when we reach the point of commercialization.

This transition is part of a long-planned evolution for the company, and Rob is the right person to lead the company with his keen understanding of sales, strategic marketing and go-to-market strategies.

I'm thrilled to be able to continue working with him in a new capacity as I turn my focus on innovating on our vector-based technology, driving research and development efforts and working with Lance on advancing our artificial intelligence applications. Please join me in congratulating Rob in his new role as CEO.

I want to thank all of you for the support you have given me as CEO and ask that you give the same support to Rob moving forward as he drives the growth of the company.

Rob?.

Thanks so much, Branislav. Let's now turn our attention to some key updates. We have a significant and growing body of clinical evidence on HeartBeam's technology.

We have nine peer-reviewed publications and presentations on studies that have collectively enrolled more than 500 patients, demonstrating the technology's potential in advancing cardiac care. These include the fundamentals of the technology as well as studies on the use of the technology in both arrhythmia and ischemia.

For both those clinical areas, we've studied the similarity of our signals to simultaneously recorded 12-lead ECGs. At the American Heart Association Conference later this month, results will be presented from a pilot study comparing our synthesized 12-lead ECG to a standard 12-lead ECG for the detection of arrhythmias.

The pilot study is a precursor to our pivotal U.S. study, which will be submitted as part of our package for FDA clearance for the 12-lead ECG synthesis. In addition, two studies were presented earlier this year on our AI algorithm in the classification of arrhythmias.

For ischemia, our study on coronary occlusions was published last year in JACC Advances. And at this month's AHA, data will be presented on a novel algorithm used in conjunction with our ECG technology in detecting heart attacks.

Beyond these clinical studies, we have more than 13,000 recordings for more than 250 people, providing meaningful insights as we learn about the performance and usability of the system. In addition to our significant body of clinical data, we continue to receive validation from our peers.

During the renowned Global Healthcare Conference in October, HeartBeam was chosen from thousands of companies and named Rising Star at the Sixth Annual Digital Health Hub Foundation Awards in the Home Health Diagnostic category. This comes months after we received a MedTech Breakthrough Award for best new ECG technology solution.

One of the main challenges in cardiac care is helping patients get the care they need in a timelier manner to prevent worse outcomes or an increased risk of death.

These awards are a validation of our dedicated team's hard work to deliver a simple way for patients to capture high fidelity ECG signals wherever they are when symptoms occur to minimize any delays in care. And with that, I'll turn it over to Tim to take us through the financials for the quarter..

utilize my past experience in leading and building strong teams to be a partner to Rob and the Board beyond the traditional CFO role and also to help provide the company with the resources and structure necessary to execute on its goals.

So I've spent the last month working with the team to further refine our strategy as well as engaging with all the key stakeholders from investors to employees. And I'm happy to say we have strong support from existing shareholders that are committed to groundbreaking technology like HeartBeam's.

Here at HeartBeam, we're focused on maintaining and adding value-add investors and we'll finance the company opportunistically to manage dilution.

With our upcoming milestones, which Rob is going to walk you through on the next slide, we're confident we have all the pieces in place to strategically capitalize the business, and we'll continue to align our cash burn to the achievement of our key milestones in advance of commercialization. Back over to you, Rob..

Thanks, Tim. We have a number of important value creation milestones, which we anticipate achieving in the coming months. First is our foundational FDA clearance.

As we've mentioned, we continue to have productive discussions with FDA, have responded to the latest set of questions and are working through clarifications, and we continue to be confident about receiving that clearance.

As we discussed previously, this foundational clearance is a major milestone for the company as it's the basis of all future submissions. Our second planned FDA 510(k) submission is for the algorithms that synthesize the 12-lead ECG from our 360-degree vector signals.

The basis of this submission is our VALID-ECG study, a 198-patient study conducted at five U.S. centers. The VALID-ECG study evaluated HeartBeam synthesized 12-lead ECG alongside simultaneously recorded standard 12-lead ECGs for arrhythmia detection.

We've completed enrollment in VALID-ECG, and we'll be submitting those results to the FDA as part of our planned second submission. We held two pre-submission meetings with FDA to discuss the study and the endpoints. As mentioned earlier, results of an 80-patient pilot study measuring the same endpoints will be presented at the AHA this month.

We're anticipating submitting the second 510(k) application soon after we receive the initial FDA clearance. We can't predict the timing of the second clearance, but we're estimating it will occur next year.

Upon the initial 510(k) clearance, we're prepared to start an early access program to provide us with important feedback on the use of the system by patients, prescribing physicians and a cardiologist reader service. Upon the 510(k) clearance for the 12-lead synthesis software, we expect to begin a limited commercial launch.

Next is our AI effort, which initially will focus on the classification of arrhythmias. As mentioned previously, we've presented clinical data on the algorithm. We're planning a clinical study called RAISE-ECG to demonstrate the performance of the AI algorithm in the classification of the signal as sinus rhythm or other arrhythmias.

After enrollment is complete, we plan to submit these results to the FDA. And in the coming months, we anticipate beginning interactions with FDA on the expansion of our clinical indication from arrhythmia to ischemic events.

And finally, we have the two clinical studies to be presented at AHA this month, and we expect to have several additional data releases next year. So in closing, we continue to be engaged in productive discussions with the FDA and continue to be optimistic we will achieve our foundational FDA clearance.

Upon the initial 510(k) clearance, we're prepared to start an early access program to provide us with important feedback on the use of the system by patients, prescribing physicians and a cardiologist reader service. Over the last quarter, we've updated the management team to better position ourselves for the upcoming commercialization.

In addition, adding Lance Myers as our Chief AI Officer and bringing Branislav's incredible capabilities to lead our technical effort will position us extremely well to continue leading in this fast-moving field.

The body of clinical evidence supporting our technology continues to grow, and we're excited to have a presence at the upcoming American Heart Association Scientific Conference next week where data on two studies on HeartBeam's technology will be presented.

While we're preparing for commercialization and strengthening our evidence base, we have a clear focus on delivering value. We have line of sight to the upcoming clinical and regulatory milestones that will help put the company a position for commercial launch in 2025.

The company remains focused on financial discipline and minimizing cash burn while delivering on milestones. I look forward to providing our shareholders with further updates in the near term. We thank you all for attending. I'd now like to open it up to Q&A.

Operator?.

[Operator Instructions] It looks like we have no phone questions at this time. We will now take questions from the web..

Our first webcast question asks, can you provide more detail on the timing of the FDA clearance? And what are the outstanding items?.

Yes, I'll take that one. It's a great question. We've provided all the information we can at present. It's just not appropriate to discuss the details of ongoing FDA discussions. But I just want to reiterate that FDA is engaged and responsive, and we're remaining very confident in our ability to achieve the FDA clearance in the near term.

And then beyond that, as we've discussed, in preparation for the commercialization, we've evolved the management team, and we're currently preparing for this early access program, which will begin after the initial FDA clearance..

Our next webcast question asks, given your cash burn, what are your plans for raising capital?.

Tim, do you want to take that one?.

Rob, thanks. Yes, important question. We're managing our cash burn really closely. And with this quarter's operating cash flow at just $3.3 million, I believe, doing an effective job headcount just around 20. So keeping a lot of cost variable related to clinical and R&D milestones.

And Rob walked you through the milestone slide where we've got really good line of sight to what we're going to be achieving over the next coming quarters. As we stated on the call, we've got strong support from existing shareholders committed to this groundbreaking technology.

And our focus is on maintaining and adding value add investors, which we believe will allow us to finance the company opportunistically, while managing dilution here in the short term.

So with our upcoming milestones, we're really confident we've got the pieces in place to capitalize the business in a strategic manner in alignment with cash requirements in advance of commercialization..

Our next webcast question asks, congratulations to Rob on his appointment to CEO, and thank you to Branislav for providing a strong succession plan.

That said, can you provide more context on the timing and the reason for the change in CEO from Branislav to Rob?.

Sure. I'll take that one. First, thank you for that. As we mentioned, the transition has been planned for a long time. Branislav and I have worked very closely together since I joined the company, which was January of 2023 and even before then, when I served as a consultant.

Branislav is -- I think he's a true visionary, but also a hands-on leader and really took the company from founding to where we are now, where we have strong clinical data, the strong pipeline of products, and we believe we're close to the first FDA clearance.

So by being at the commercial stage now, Branislav long thought this is the right time for a transition and having this company led by someone with more of a commercial background.

I've been fortunate to have worked with a number of groundbreaking technologies from one of the first drug-eluting stents to pioneering lasers for cataract surgery to FFR-CT that noninvasively measures blood flow.

And I think what I learned from those developing and executing those go-to-market strategies really has prepared me well for the stage that HeartBeam is at in our upcoming introduction into the market. So I just -- I guess I want to finish by just emphasizing that Branislav is going to stay deeply involved with the company.

He's going to lead all of the technical efforts. So advanced R&D, our development projects and the AI efforts. So the company is going to continue to benefit from his skills and his energy as we go forward. Branislav and I have had a close partnership, and that's definitely going to continue going forward..

Our next question asks, can you provide an update on how the timing and results of the VALID-ECG study?.

Sure. Happy to take that one as well. So the VALID-ECG study, just as a quick reminder, this is the 198-patient study at five U.S. centers, and it had simultaneously recorded HeartBeam signals and standard 12-lead ECGs. And we -- as we mentioned before, we've completed enrollment.

We have analyzed the data, and it will be the basis of this upcoming second FDA submission on the 12-lead synthesis. Unfortunately, we can't talk about the results because the data have not yet been peer-reviewed, and it is the basis of that submission. But I did want to draw everyone's attention to the upcoming data at the American Heart Association.

It's going to be in about 10 days. That presentation is on the results of the 80-patient pilot study that measures the same endpoints as VALID-ECG..

And our last webcast question asks, if everything goes right with the FDA, what could 2025 revenues look like for HeartBeam?.

Yes, Tim, why don't you take that one?.

Sure. I mean the opportunity in front of us is massive. This is such an exciting opportunity. And this is a question I can't wait to answer in more detail in future quarters. I'd say, for now, I think the company stated in previous quarters, we don't anticipate significant revenue in 2025.

But of course, we're going to be working to bring forward timelines and expectations wherever possible and of course, updating the market on our progress throughout 2025. You saw the slide where we give a real solid roadmap of the milestones that we're laser-focused on.

And on the back of our upcoming FDA clearance, I think it's critical we take the time now to market the HeartBeam system through this early access program. That's kind of our initial beta, if you will, commercial launch.

So getting the critical user feedback for our go-to-market strategy, refining our pricing models, we're going to be gaining all of that information, that critical information in the coming quarters. And that will give us the biggest impact on our commercial launch when it comes..

That concludes our webcast questions..

I would now like to turn the call back over to Mr. Rob Eno for his closing remarks..

Thank you, operator. I'd like to thank each of you for joining our earnings conference call today. It's going to be an exciting few months ahead for the company as we look to achieve a number of critical milestones in the very near term. We look forward to continuing to update you on our ongoing progress and growth as we close out the 2024 year.

If we were unable to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist..

Ladies and gentlemen, this concludes today's conference call and webcast. Thank you for your participation. You may now disconnect..