Conferencia de resultados del T2 de 2026 de HeartBeam (BEAT): presentación ante la FDA, menor consumo de efectivo y lanzamiento comercial

Conclusiones clave

• HeartBeam registró una pérdida neta de 5,0 millones de dólares en el segundo trimestre de 2026. La dirección señaló que la pérdida subyacente fue de aproximadamente 4,1 millones de dólares tras excluir cerca de 0,9 millones de dólares en costes extraordinarios por la transición de liderazgo.
• El efectivo neto utilizado en actividades de explotación fue de 3,3 millones de dólares, lo que supone un descenso del 7% respecto al primer trimestre de 2026 y del 3% interanual. La empresa cerró junio con 8,8 millones de dólares en efectivo, equivalentes de efectivo y efectivo restringido.
• La dirección prevé que la salida de efectivo de explotación para todo el ejercicio 2026 se mantenga por debajo de los 14 millones de dólares. Se espera que el uso trimestral de efectivo de explotación de referencia caiga por debajo de los 2,5 millones de dólares en el cuarto trimestre, sujeto al gasto en el estudio pivotal y a los cobros de clientes.
• El mismo día de la conferencia, HeartBeam presentó una solicitud previa ante la FDA para la indicación de detección de ataques cardíacos, proponiendo la vía 510(k). La dirección se muestra cautelosamente optimista respecto a que un ensayo pivotal pueda comenzar antes de fin de año.
• El lanzamiento comercial avanza en Nueva York, Dallas, el sur de Florida y el sur de California. Ya se han enviado los primeros pedidos, se está incorporando a los pacientes y los acuerdos firmados cubren actualmente a miles de pacientes potenciales.
• HeartBeam indicó que ahora menos de 30.000 pacientes podrían ser suficientes para alcanzar el umbral de rentabilidad del flujo de caja bajo su estructura de costes reducida, aunque el calendario de adopción comercial sigue siendo incierto.

Datos financieros principales

Evolución operativa y del negocio

HeartBeam completó el desarrollo de su sistema HeartBeam del tamaño de una tarjeta de crédito y un prototipo funcional de su parche ECG de 12 derivaciones. La dirección afirmó que la finalización de estos proyectos debería contribuir a reducir la base de costes de la empresa.

El despliegue comercial sigue centrado en la medicina de atención personalizada (concierge). HeartBeam cuenta con acuerdos en cuatro regiones clave de Estados Unidos, con los primeros pedidos enviados y los primeros pacientes incorporándose. La dirección prevé que el flujo de pedidos aumente a finales del tercer trimestre, a medida que los centros pasen de las pruebas internas a la identificación de pacientes adecuados.

La empresa está integrando HeartBeam en los flujos de trabajo de admisión de nuevos pacientes. Los pacientes reciben un ECG de referencia de 12 derivaciones, tras lo cual los médicos pueden determinar si aplican la tarjeta HeartBeam. La dirección señaló esta integración en el flujo de trabajo como la lección principal del lanzamiento inicial.

HeartBeam estimó que aproximadamente 1,9 millones de pacientes participan en programas de atención personalizada (concierge), y la dirección sugirió que cerca del 20% o más podrían tener necesidades cardíacas. Los contratos firmados actualmente cubren a miles de pacientes, pero la empresa planea esperar a tener más datos de adopción del tercer trimestre antes de ofrecer métricas comerciales más detalladas.

La detección del ataque cardíaco sigue siendo la máxima prioridad de desarrollo. El ensayo piloto ALIGN-ACS reclutó a 134 pacientes de urgencias en menos de cuatro meses, y sus resultados fueron aceptados para una presentación completa en el congreso TCT. El estudio HEADSTART-ACS con 500 pacientes en Indonesia superó el 50% de inscripción en menos de tres meses. Un ensayo piloto independiente que evalúa el parche en aproximadamente 50 pacientes también avanza en la inscripción a un ritmo superior al previsto.

Actualmente, HeartBeam prioriza a Indonesia como su único mercado internacional principal fuera de Estados Unidos. La empresa colabora con el Ministerio de Sanidad de Indonesia y señaló que la estructura comercial definitiva podría incluir licencias, aunque esto no se ha determinado.

Orientación de la dirección

La dirección prevé que el uso de efectivo de explotación de referencia disminuya por debajo de los 2,5 millones de dólares por trimestre en el cuarto trimestre de 2026. El tercer trimestre podría incluir costes adicionales vinculados a la transición de liderazgo y a los pagos finales derivados de cambios de contratistas.

El gasto podría superar el nivel de referencia del cuarto trimestre si HeartBeam inicia y recluta rápidamente pacientes para un estudio pivotal sobre detección de ataques cardíacos. Se prevé que los cobros en efectivo de clientes procedentes del lanzamiento comercial inicial compensen parcialmente este impacto durante el segundo semestre de 2026.

La empresa prevé una salida de efectivo de explotación para todo el ejercicio por debajo de los 14 millones de dólares y afirmó que su horizonte de liquidez se extiende ahora más adentrado en 2027 de lo indicado anteriormente.

La dirección prevé un mayor volumen de pedidos para finales del tercer trimestre y anticipa tener una mejor visibilidad a finales de año sobre el ritmo de crecimiento comercial en 2027. No se facilitó ningún objetivo específico de ingresos.

Riesgos y aspectos clave a supervisar

• Los comentarios de la FDA podrían modificar el diseño, el tamaño, el coste o el calendario del estudio pivotal propuesto. La empresa aún no ha determinado el número de pacientes necesario.
• El despliegue comercial se encuentra todavía en una fase temprana y la adopción depende de una integración con éxito en los flujos de trabajo de la medicina de atención personalizada (concierge).
• El inicio del estudio pivotal antes de fin de año podría elevar el uso de efectivo de explotación por encima del nivel de referencia de la dirección para el cuarto trimestre.
• Los ingresos y los cobros en efectivo de los clientes apenas están empezando a despegar, mientras que la empresa sigue consumiendo efectivo.
• La expansión internacional se concentra actualmente en Indonesia, donde la estructura comercial y la posible concesión de licencias aún están por determinar.

Puntos destacados del turno de preguntas y respuestas con analistas

La dirección aclaró que su estrategia de alianzas a corto plazo se centra principalmente en integrar la tecnología de HeartBeam en grandes redes de atención médica, en lugar de recurrir a licencias tecnológicas convencionales. Podría surgir con el tiempo un modelo de licencias en Indonesia, en función de los resultados de los ensayos y de las conversaciones con el Ministerio de Sanidad.

Respecto a la estrategia ante la FDA, HeartBeam confirmó que propuso la vía 510(k) para la indicación de detección de ataques cardíacos. La FDA dispone de un plazo de respuesta de 75 días para la solicitud previa, y la dirección cree que el estudio pivotal podría comenzar antes de finales de 2026 si las conversaciones avanzan según lo previsto.

En cuanto a la comercialización, la dirección afirmó que las cuatro regiones geográficas clave de Estados Unidos contienen un grupo de pacientes lo suficientemente amplio como para respaldar sus objetivos. La empresa sigue considerando que aproximadamente 30.000 pacientes es el umbral histórico para alcanzar el punto de equilibrio en el flujo de caja, y la estructura de costes actual podría reducir ese requisito por debajo de los 30.000.

La dirección también confirmó que la capacidad de fabricación podría respaldar una eventual aceleración comercial en 2027.

Transcripción completa de la conferencia de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

Operator

[Operator Instructions] 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, Richard Ferrari, Executive Chairman; Branislav Vajdic, Founder and President; and Timothy Cruickshank, Chief Financial Officer, will present results of operations for the second quarter ended June 30, 2026. At this time, I will turn the call over to HeartBeam Executive Chairman, Mr. Richard Ferrari.

Richard Ferrari

Good afternoon, everyone, and thank you for taking the time. I know your schedules are very busy. We have a nice, tight presentation to provide for you, and the agenda, as you can see, I will walk through those elements: the core technology, our highlights, heart attack detection, our initial commercial launch, and the financials.

So if we go to the next slide. Are we on the next slide? Yes, we are. Just if you could, because I can't see whether or not we've moved to the next slide, just let me know that that slide is up. As you can see from this slide, this to me really frames what really gets all of us at HeartBeam incredibly excited, is the fact that every 40 seconds someone suffers from a heart attack. Our technology, which is utilizing [ tri-core ] signal capturing technology, is the only true way to evaluate the real extent of that trauma. To reach as many of these patients as possible, we've developed and tested three different form factors, each with a unique approach. As you already know, the card fits into the post-discharge space where many patients, we feel, will find comfort knowing they have a way to monitor their heart health.

The patch fits into the emergency room workflow and in-hospital monitoring of at-risk cardiac patients, greatly reducing the time required to obtain a medical-grade 12-lead EKG and have that information ready to read in near real time. And the HeartBeam remote unit, which fits the needs of a device that patients can have access to in remote locations. I will touch base a bit and go through the presentation on this, but as you can see there, the card is on the far left, and this particular form factor is simply ideal for post-discharge monitoring. That is, patients that leave the hospital and need some way to feel some peace of mind at home in which, if they feel something, they can take a reading. They have near-time response to that via the 24-hour reading service, and they can have something that's actionable. They can determine what they need to do via that reading from the physician.

The on-demand patch is probably the most exciting form factor from my perspective. This is a device that has extended monitoring with an on-demand 12-lead capability. So it covers two things: 24-hour monitoring, as well as, once again, two fingers on those two electrodes, north and south, that you see in that picture, and you get a medical-grade 12-lead EKG. We will be positioning this device for emergency room departments and post-procedure in-hospital monitoring. For example, patients that go into the hospital that have an ablation procedure, that came into the emergency room having a myocardial infarction, someone that's had cardiac surgery, someone that's received stents. Many of these patients are held in the hospital for a day or 2 and then moved to a step-down unit. Just imagine the fact that all they would need to do is have a patch, and literally the nurse or the physician can just ask the patient to put two fingers on those electrodes, and they would get in near real time a true 12-lead EKG. This fits into the workflow and eliminates a lot of time that finding an EKG tech to come up from a floor, put on the sticky devices, and so forth. We see this as just completely disrupting really the entire space.

And you've heard us talk about the HeartBeam remote unit. This is a form factor, again, using all the same technology. This is the form factor that we're currently using over in Indonesia, and we'll touch base on that so that we can get patients almost anywhere where they are access in an authorized way and understanding of what's going on with their heart health. Next slide, please.

Okay, if we look at the HeartBeam core technology and platform, every medical device company spends a great deal of time building a moat around their intellectual property. That's exactly what HeartBeam's been doing. We now have 25 issued patents worldwide that are incorporating our proprietary technology, the [ tri-core ] 3D signal reconstruction. Essentially, we have the single best signal capturing device for the interrogation of an EKG signal. That provides us with enormous opportunities to change the way patients will be interfacing with their physicians and their own personal cardiac health. And as I think most of you know, this has been clinically validated. We have run numerous studies, which I'll touch on before. The FDA has cleared us for arrhythmic assessment, and the body of evidence supporting expansion into heart attack detection and future indications is currently going on. I will also touch base in a minute on where we are with that initiative, but we have now done hundreds and hundreds and hundreds of patients using our current technology.

We don't see it as a product, of course, we see what we are doing as a platform because you can see that the technology is embedded into three different form factors, and this opportunity addresses a fundamental gap in care by providing clinical-grade 12-lead EKGs through multiple form factors. There's just no other technology that we're aware of that does exactly what we're doing. And we have designed this architecture that we're using to enable our technology to be used in the card, the patch, and then in the HeartBeam remote. Next slide.

So if you look at those key strategic priorities, top of the heap for us is heart attack detection. We are rapidly advancing the initiatives around the indication for heart attack detection. Our clinical validation efforts are ahead of schedule in terms of this particular initiative. You notice on this slide we have the pre-sub submitted to the FDA imminently. Well, I'm happy to tell you that we actually did submit the pre-sub today, and we are developing additional go-to-market and reimbursement approaches as we are working through the FDA to get approval for heart attack detection. This will again revolutionize how patients, physicians, and hospitals are looking at cardiac health.

You also know that we began initial commercial launch. That is underway. And I think you might recall that the first half of the year we referenced the fact that this was our learning stage. And that the second half of the year we would be beginning to gain momentum in generating revenue. That's exactly what we're doing. We are generating real-world deployment evidence with positive feedback from physicians and patients, and I'll touch base on that in just a minute. And that is creating a strong foundation for accelerated growth. The concierge vertical for us is a very nice vertical. There is a real need there. There are many patients, almost 2 million patients embedded into concierge services, in which many of them are at-risk cardiac patients, and the physicians and the patients are looking for something that provides them with peace of mind and real-term interpretation of their cardiac health.

And then the integrated network partnerships. This is something that I mentioned. We are reaching out to large integrated networks to work with them and run pilots to see how our technology would be incorporated into their workflow. And the two workflows that we are working on that are of particular interest, obviously, is the emergency room department, when patients come in feeling chest pain. How can we implement our technology in that setting? And then the setting where patients have had a post-procedure and they remain in the hospital under observation, how best can we utilize our technology in those settings? These integrated networks, as you well know, have an enormous number of patients. One of the ones that we're talking to has 50 million visits a year. And that's not to the emergency room. To the emergency room, it's in the many millions. And the number of interventional procedures is north of 100,000. So just in that 1 particular instance, you could see the power of integrating HeartBeam into that workflow to eliminate and streamline how they're interacting with the patient and getting real-time information. Next slide.

I'll touch base now on some more of the recent operational highlights. Next slide. And again, as I mentioned to you, at the pinnacle of what we're really driving forward on is heart attack detection. Again, to us at HeartBeam, and I think to the physicians that we speak to, this is an exciting area as you could really imagine. To have a device that you can either wear or carry with you that would have an actionable response when a patient is having chest pain and can determine whether or not that's a heart attack, and in near real time have a reading of that to get that patient to the hospital changes the equation dramatically. And we know we can do that because we have run several clinical studies that are shown here on this particular slide.

So we completed enrollment of the ALIGN-ACS pilot study in less than 4 months. So again, when I tell you that the technology is very exciting and the interest level and the utilization of this technology is very exciting, that's the proof set. Every medical device company that ever runs a clinical trial is constantly trying to accelerate the finish of that clinical trial. It's probably the area in which most attention is placed when that clinical trial is run. We finished in less than 4 months. That tells you there's real enthusiasm. That's 134 patients that have walked into emergency rooms with chest pain where they had a 12-lead EKG, and that reading was compared to the HeartBeam. And those results were quite superb. And in fact, they passed the criteria to be accepted at the TCT, which will be held later on this year in October and November, as a full presentation. Very exciting body of data.

The HEADSTART-ACS pilot study, we've already surpassed 50% enrollment in less than 3 months. Again, another testimony to the excitement of the physicians and the nurses that are involved in this particular study. It is a 500-patient study. This is the one that is being supported by the Indonesian government, evaluating the accuracy again of the HeartBeam ECG technology in detecting heart attacks in a real-world setting. And of course, that study, our hope is we'll move forward to incorporation into their workflow in their large hospitals and some of their remote settings. And that is a gigantic market, 280 million people in that market alone. Additionally, we have an article coming out in JACC that advances the demonstration that an algorithm combining the HeartBeam ECG device, patient risk factors, and symptoms can accurately identify heart attack in patients. Again, incredibly exciting study. The patch study, we initiated a pilot study evaluating the patch in approximately 50 patients. That is also enrolling ahead of speed in the same two hospitals that we ran the ALIGN-ACS study.

And with respect to the regulatory, the results from all of these clinical studies is what we have been using in our discussions with the FDA when we're discussing approval for heart attack assessment indication. As I mentioned to you, the pre-sub has been in fact submitted as of today. And we're very, very excited about that. In this particular case, you know, the FDA has 75 days when you submit a pre-sub to get back to the company with additional information or not. And that begins the process immediately for enabling the company to move forward with a pivotal trial. So we're very cautiously optimistic with what we've been able to achieve there. Next slide, please.

In carrying on with Q2 2026 and some of the other highlights, we obviously completed the working prototype for the 12-lead EKG patch. This is the first ambulatory patch device designed to aid in detecting ischemia and complex arrhythmias. The patch market alone is $2 billion in revenue. And there is a video that is embedded into this particular slide, which unfortunately we can't take a look at now, but I would encourage anyone that is later, when you have time, to click on that video if you haven't seen it and just watch it. It's only 50 seconds long. And just imagine how this patch will fit into the in-hospital workflow and also post-discharge workflow. But the in-hospital workflow, where a nurse or a physician needs to have a reading on a patient that is held in that hospital, and all they have to do is put two fingers on those two electrodes versus having to run down an EKG tech, come up to the floor, get a reading of the 12-lead EKG, and not actually see those results for hours and hours later versus seeing that information in real time.

Additionally, I think you may have noticed we've had press releases regarding the expansion of two new patents. These are again two patents for the future of where we see our technology going. One is for acoustic sensors and one is for fluid monitoring. Now, acoustic sensing is a way to interrogate information that would give us insights into how the valves of the heart are performing. And the fluid monitoring capabilities is using impedance to determine whether or not a patient's fluid is increasing, and as many of you may know with congestive heart failure patients, this is the big gotcha. Patients eat a bag of potato chips, they become overloaded with fluid, they call 911, they're rushed to the emergency room. But if they could determine at home what the situation is because of our reading service and their physician, they could most likely titrate their drugs right then and there. So two future aspects that are very, very exciting for our technology. Next slide.

On the commercial traction, and I'm going to move on this slide from the left to the right. As you well know, we commercially released this product. Now, commercial release of a product like this sounds like a very simple thing. But to incorporate the end-to-end 24-hour reader service, the onboarding workflow, and have customer success at that level is a tremendous undertaking, which we've been able to do. And that 24/7 reader service is a key differentiator for our offering, something the physicians and the patients truly value. So we are working now directly with practices on this rollout and planning workflow integration and implementation processes with those concierge practices that we have already signed up.

Moving to the right, as you well know from Brian, and by the way, I would say Brian would be on this call today addressing this particular slide, but he's on sort of a road trip with his daughter looking at colleges. But we already have several agreements now in place covering all four of the target markets that we're most interested in initially. They're noted there in New York, Dallas, South Florida, Southern California. The first orders have shipped and initial patients are being onboarded as we speak, and I can tell you that we are seeing real green shoots in this particular area. The way this process works, as you might imagine, in the concierge practices, it's the doctors and the nurses and a couple of the select patients that get the device first. They see how the device works. Are the readings accurate? Are they sharp? Are there any interruptions in any of the workflow? Once they get past that, which is generally quite short, 2 weeks or so, the next stage is then to look at their patient pool and identify those patients that would be best served by having the HeartBeam technology, and that's where we are now. And you will see at the end of Q3 an increasing magnitude, I would call it, in terms of the order flow.

So getting the HeartBeam embedded into those workflows is critically important. And we have created a program that incorporates HeartBeam into the new patient intake at the concierge practices. This is one of the areas that the concierge physicians are very, very interested in, is the patient comes in right up front, being able to integrate that patient immediately with HeartBeam. And that we believe will in fact accelerate adoption. And I think over on the far right-hand corner, we've strategically selected these practices and we will continue to contract with them. Brian has a very nice and robust list, and we're going to continue. And in a minute, you'll see a little testimony to one of these practices and how they think about our technology. Next slide, please.

So what have we learned from the first 6 months in the process that we're in now? The EKG quality. There has not been a single physician that has our HeartBeam technology that is not absolutely impressed with the quality of the 12-lead EKG from a pocket-sized device. In fact, I would tell you, they're just truly amazed because they've never seen anything like it. They all know that 12-lead is the standard. And to have such quality is something that is truly impressive. Consequently, the patient has the same sense, right? Patients have indicated their comfort in having the same quality ECG that they would receive in an office or a hospital. And the patient engagement, the onboarding of patients as we've gone through this, and they're comparing to themselves patients. So when an EKG tech puts all of the leads on them versus all they need to do is take the card, put it up to their chest, and put two fingers on the electrodes, and they get real-time results. A 12-lead readout that they can see, our 24-hour service sees, and the physician sees, has really just opened up the opportunity in just an enormous way. Next slide, please.

Now, this is a physician perspective. Now, Dr. Ram has a practice that's particularly large, [ Generation Health ] in Beverly Hills. He was the former Chief of Cardiology at Cedars-Sinai. So this is a top-notch physician. And I'm not going to read every point on the right-hand side. But again, I will point you to his statements. It is amazing to have a 12-lead device in your pocket. This is what we've been waiting for. What he really enjoys about the technology is that he has a baseline with the HeartBeam so that any time any of his patients have an event or a symptom, and he gets a new reading, it's compared against the baseline, which enables him to really understand what's going on with his patients and respond appropriately with some kind of actionable event. This is just critical for this kind of service. Next slide, please.

Now, this is Jerry. Now, Jerry, you might say, gee, we hand-selected this individual, 85-year-old patient, Air Force veteran. He represents the at-risk cardiac patients, 8 or so million of them running around the United States, a good 2 million of them inside concierge practices. This is an individual who sees the HeartBeam device as incorporated into his quality of life. You can see his statements. When I take a HeartBeam recording because something feels off, there's an instantaneous readout to my doctor. I don't need to wait hours or days. How important is that to this kind of a patient? And he goes on in his frame of reference, it's a piece of cake to use even for himself, who is not, let's call it technology astute. But he goes on to say every morning he checks his blood pressure, and every morning he gets an EKG reading, and that gives him comfort. He represents just 1 of millions of patients in which our technology is going to impact. So I'm going to stop there. I'm going to turn this over to Tim on the financials.

Timothy Cruickshank

Great. Thanks, Rich. Great updates. Let's take a look at the Q2 2026 financials here. We'll focus on cash flow first. Net cash used in operating activities, $3.3 million for the quarter. That's a 7% decrease in operating cash outflow compared to the first quarter of 2026, also a 3% decrease compared to the same quarter in the prior year. Over the course of the year, particularly in this past quarter, Q2 2026, we were hyper-focused on ensuring a tightly managed cost profile. We continue to do that as we gather these learnings that you saw from a commercial launch standpoint and as we advance the key initiatives like heart attack detection and other strategic initiatives. So we found ways to heighten our efficiency and do more with even less resources over the past quarter.

A few examples of that, we focused on curtailing and pausing projects with contractors that weren't directly associated with our key initiatives. So anywhere it was tangential, not directly related, we were able to turn some projects off, continue to gain efficiencies across the organization through AI tools. It's amazing to see what the team can do from R&D to coding to marketing, lots of different opportunities. Executives and employees of the company elected to receive shares in lieu of cash in the settlement of the 2025 bonus program. So this reduced our operating cash outflow by a little over $1 million and also is a testament to the commitment of our team and the tremendous upside we all see in this opportunity. So wanting to align ourselves with shareholders every way possible.

So we concluded the product development of our credit card-sized device, the HeartBeam system. We also completed development of the prototype 12-lead patch. So those were significant expenditures throughout the last few quarters that now are effectively complete and will help continue to reduce our cost profile. So all this leads to our baseline Q4 2026 operating cash flow stepping down to around below $2.5 million per quarter. So Q3, we'll see some additional noise related to the leadership transition, as well as some final cash flow-related payments from some of these contract changes we made, but by the time we get into Q4, you'll see this step down to that sub-$2.5 million. So it's just amazing the effort the team has been able to do to do as much as possible with the fewest resources.

And two factors to bear in mind in the sub-$2.5 million number for Q4, the timing of both commencing the pivotal study for MI and the speed at which we enroll patients may increase us beyond that baseline spend, but that will be a great problem to have, and given what we're seeing with enrollment times in our two current MI studies and the collaborative work with the FDA, things are trending really positively there that we will be spending into that trial before the end of the year. But partially offsetting that spend will be cash receipts from customers in the second half of the year from the beginnings of our commercial launch from a revenue and cash perspective, as we see over the next 6 months. So quite a few puts and takes on the baseline spend, but those are kind of the two big factors. All in all, we're trending to come in below $14 million for operating cash outflows for the full year for 2026.

On our last call, we noted the capital raise we completed in April of 2026. That strengthened our financial position, $11.5 million common stock only financing. So at June 30th, net of the spend from the quarter, cash, cash equivalents and restricted cash sold $8.8 million. Now with our reduced cost profile, we've extended our cash runway a bit further into 2027 than we previously indicated, and we'll continue to find ways to extend it further.

Let's just quickly go on the next slide. We've got net loss for the quarter, $5 million, Q2 2026, and EPS and net loss were directly in line with our expectations. And 1 item of note on net loss and the purpose of this slide here, the box in the bottom right, there's about $0.9 million of one-time items in that $5 million net loss number, both related to the previously announced leadership transition. So we've got $600,000 of non-cash stock-based compensation driven by vesting of awards and equity related to the former CEO, as well as $4.3 million related to severance accrual payable to the former CEO. So those two things being one-time in nature implies the underlying net loss in the quarter, more like a $4.1 million loss. So that would have been a 12% decrease compared to the prior quarter and 17% decrease compared to the same quarter in the prior year if not for the one-off items. Just to show the proof statements of how the net loss is coming down over the balance of this half-year work already being done in this prior quarter, but there'll be a lot of evidence of that by the time we roll into Q4.

So in summary, we continue to gain organizational efficiencies, do more with less, but we're focused in Q2 on gathering learnings from the commercial launch, finding ways to accelerate key R&D and strategic initiatives, namely what Rich walked you through with the heart attack detection program. These efforts had the coupling effect of extending our cash runway and very likely significantly reducing expected timelines related to that heart attack detection program and indication expansion. So we'll continue over the balance of this year to make steady progress on these fronts, as well as with our initial commercial rollout. With that, Rich, I'll hand it back over to you.

Richard Ferrari

Okay, thanks, Tim. You know, on the summary slide here, just to sort of recap what I walked through, this is really a gigantic opportunity that's in front of us, and HeartBeam is at the tip of the spear with the kind of technology that is really going to fit for what both physicians, networks, and patients are looking for. This is a proven technology with an incredibly strong IP and a growing body of clinical evidence, which I've touched on between the trials and the papers. The proprietary [ tri-core ] technology is something that I can't overstate. I mean, it enables us to do things and capture the signal from a patient that others just simply cannot do. The richness of this signal is what makes all the difference in the quality of the interpretation. It also will come in for future advances in how that signal capturing technology is utilized through AI and other mechanisms.

So when you look again at the card and the patch there to the right, just think about how impactful that's going to be for a large number of at-risk cardiac patients. This technology is doing what other technologies currently are not capable of doing in a wireless format. Tim has already walked through the capital-efficient strategy based around our core priorities. We will stick to those core priorities. That is our focus. Heart attack detection is immensely disruptive. We feel very confident in how our technology works against a standard 12-lead EKG. Obviously, the clinical studies have proven that out, and papers that have been accepted have been of extremely high quality.

And now we have the submission to the FDA, the pre-sub, and obviously we'll have some ongoing dialogue with them. But in the end, we'll be moving towards approval via clinical trial by year-end. The initial commercial launch, I think I've touched base on that. Brian has expressed how we will roll that out. Green shoots are showing there, and we fully expect this will accelerate now that we have a very good process and an intake strategy with these concierge services. And I'm personally very excited about working in the integrated network partnership arena. I believe that there are so many hospitals and rural hospitals, but large networks, where the patch and the card, coupled together, the emergency room, and post-procedures will really change the workflow within a hospital. It'll benefit the hospital in many, many ways in terms of its own cost structure, but it'll also immensely benefit the patients because the fact that you can get this information in near real time is so critically important to making decisions around a patient's health or whether or not they need to intervene further. So I will stop there. And I believe we're going to open it up to some Q&A. I'm glad to expand on any questions that someone may have.

Operator

[Operator Instructions] Your first question comes from the line of Jeremy Perlman with Maxim Group. Please go ahead.

Preguntas y respuestas

Jeremy Perlman

Good afternoon. Thank you for taking my question. First, a really thorough overview of the company and where it stands commercially. Recently, you mentioned in a press release a strategic shift to also, in addition to your direct medical device sales, also focusing on licensing out the data that you generate through your synthesized 12-lead ECG. Maybe you can provide some more specificity around the types of partners you're targeting, what applications you think will be the most commercially attractive, and then what would a successful licensing relationship look like? Thanks.

Richard Ferrari

Yes, thanks for the question. I think licensing may have been a bit of kind of an overstatement because it's embedded into the concept, basically the concept and the initiative of working with the integrated systems to incorporate our technology into their workflow. That's what I was referring to with respect to licensing. That is more of a partnership than it is a direct licensing of the technology. So we have not been doing much work in the sense of a license in the purest sense. We're doing the work around partnering with those networks in which the technology could be incorporated into their workflow. Now, having said that, and yet to be determined, what we're doing with the Ministry of Health in Indonesia may, in fact, represent a licensing strategy, but that's yet to be determined until we finish the trial and we get into further discussions with them.

Jeremy Perlman

Okay, understood. Great. And then maybe also, I know a part of that you mentioned that you wanted to accelerate global adoption, aside from the trial going on in Indonesia, what other international markets are you prioritizing?

Richard Ferrari

Well, I mean, to be straightforward, right now we're only prioritizing the work with the Ministry of Health in Indonesia because that, I believe, holds for us the key in how that 1 form factor could fit into other settings outside of the United States. So we're going to use that as getting to first base, understanding how that technology has been implemented in that particular very, very large population of people, and then we'll move on from there. So we'll keep that one where it is. Yep, we'll continue to work on that one. But all of our focus besides that is in the United States.

Jeremy Perlman

Right, understood. And then, yes, so then maybe just last question, shifting back to the United States, you know, your just initial, you know, commercial rollout to the concierge practices. Maybe if you could discuss what do you have, how big is that opportunity? Maybe how many patients, you know, have you calculated are full under that umbrella of this, you know, concierge or preventative cardiac care and then you know and what is that runway look how do you how do you you know what what's the break even maybe how many patients you think you could onboard in the next let's say 12 months thanks.

Richard Ferrari

Well, I can tell you, and Tim, you can correct me if I'm off base here because I don't have this number directly in front of me. But I believe within the concierge practices that we're talking in, there are 1.9 million that are embedded into these concierge programs. So that is a large volume of patients. Of course, not all of them are, quote, cardiac patients, but you can imagine that in and around 20% or so of those or more are likely cardiac-oriented patients, kind of like the [ Generation Health ] and that patient, Jerry, he's seeing more and more of those kinds of patients. So that, in and of itself, is a very, very nice market in and of itself. That's hundreds of thousands of patients that could, in fact, gain value from the HeartBeam technology.

Now, the question I think you're really referring to is how fast can we roll it out? Well, we're determining that now. We're seeing that the ones that we're working with represent very, relatively large concierge practices, and we're now collecting the metrics around how many patients within each of those practices would be applicable for what we're doing. But generally speaking, I think at the end of this year we'll have a very good visibility into how rapidly 2027 basically grow, but I can tell you that the green shoots that we're seeing and the enthusiasm and the excitement from the ones that we're dealing with, I think looks quite reasonable.

Jeremy Perlman

Okay, great. And then just from a manufacturing perspective, you could easily have the capabilities for the ramp in 2027?

Richard Ferrari

Yes. The answer is yes.

Operator

Your next question comes from the line of Josh Jennings with TD Cowen. Please go ahead.

Josh Jennings

Program coming online in Europe. How material do you expect the GDC to be towards the revenue-

Timothy Cruickshank

Hey, Josh. It could be something where you see a few more systems get placed. Excuse me, Josh Jennings, are you there?

Operator

He may have had to switch over to another call. We can come back to him. Yes, I can't hear him. Your next question comes from the line of Yi Chen with H.C. Wainwright. Please go ahead.

Unknown Analyst

Hey, this is Katie on for Yi. I guess thinking about the FDA filing from today, what indication and regulatory pathway did you propose? Kind of assuming that 75-day window, when do you think that pivotal could begin and number of patients, et cetera, for that?

Branislav Vajdic

Yes, we went down the 510(k) path. The team did an incredible amount of work in providing the FDA with the kind of information and backup information that would be required for that. So that is the pathway we went down. That's, as you might know, very exciting to us. Now, the FDA, with this particular filing, will review, quote, that information that we presented and our justification around that particular strategy.

Richard Ferrari

I can't tell you yet what size of a clinical trial that might be required. It would be sort of premature for me to say what that would be. But quite frankly, based on the fact that there were predicates that we identified, and it's a 510(k), I wouldn't expect the trial to be of an exorbitant number. Based on the fact and the proof statements of the trials that we have previously run that have all been completed ahead of their schedules, I think we feel cautiously optimistic we could start the trial before year-end.

Operator

Great, thank you. Your next question comes from the line of Kyle Bauser with Titan Partners. Please go ahead.

Kyle Bauser

Great, thank you and appreciate all the updates here. So maybe just on the kind of commercial efforts, having signed multiple agreements across your four targeted U.S. geographies. Any sense as to kind of the number of covered lives that that group of agreements kind of captures? Understand the 1.5 million concierge market as being kind of the initial opportunity, but just trying to get a sense of the number of covered lives and certainly those four geographies probably capture significant opportunity within that initial target.

Richard Ferrari

Tim, I'm going to, if you wouldn't mind, could you answer that particular question? Because I don't have that number.

Timothy Cruickshank

Sure. Yes, no problem, Kyle. Good to hear from you and connect. Yes, the four primary geographies cover the majority of the population or in terms of the pool that we're going after. So that's why we selected those four geographies. In terms of the contract signed to date, we're still talking in the thousands. The reason we haven't provided more detailed metrics on this is it's still just early days. We want to get through Q3 and really start to see the order come in and roll this out, you know, to start to provide those metrics. But we're talking thousands of patients. We just don't want to get ahead of our skis too fast early days because it's really about the workflows.

As soon as we have those workflows figured out, like what Rich talked about with all new patients coming in now, getting a baseline 12-lead EKG, and getting fitted for our technology and the option to, you know, to sign up through the concierge practice, that's been the number 1 priority over, you know, kind of number of covered lives in the short term. But our goal is still to get, you know, if we kind of work backwards on what we're trying to accomplish, you know, we've told the market historically, it's about 30,000 patients to get to break even or cash flow positive. That's still a true statement. And it's probably even less now based on our current cost profile that we have. So sub-30,000 patients to get there.

We believe in these four geographies, there's enough patients in the pool, you know, as we continue to sign agreements and make traction to cover that. And it all comes down to, you know, when in 2027, you know, do we feel the momentum picking up? What we've seen with MI detection and how fast that's moving forward. You know, ideally the goal will be to make really strong headways into this market, but the intersection of when MI comes on, you know, if that continues to speed up, hopefully, you know, we get to the point where we're talking about that market and what penetration and commercialization looks like into that before we even need to talk about 30,000 patients in the concierge space.

Kyle Bauser

Right. No, makes sense. Appreciate that, Tim. And maybe for my follow-up, just a two-part question on learnings so far and how you think they'll kind of influence how you move forward. So first on the heart attack patient pivotal study, you talked a little bit about this. You've been able to enroll very quickly, which has been impressive and maybe not terribly surprising just given the favorable way you're able to enroll through ERs. But can you talk about any learnings you've had from these pilot studies and how they've kind of influenced your submission and interaction with the FDA for the pivotal and then on commercial efforts, any sort of learnings for onboarding? Do you feel like you've been able to do that nicely for the first order shipped and patients onboarded there. Anything that you've learned that's helping you to kind of move forward?

Richard Ferrari

Branislav, why don't you answer the first part of that question? Because I know that you've been very intimately involved in those initiatives.

Branislav Vajdic

Yes, absolutely. So the benefit of the pilot study we just finished is twofold. One and foremost are the results, right? The performance of our technology against the 12-lead ECG. And a good indication of how well we have done is an accepted presentation at the prestigious TCT, International Cardiologist Conference, right? So we are very pleased with what we have seen in terms of results on this pilot study. The second, perhaps a bit less, but it's very important aspect is the execution, right? Many of these studies run into problems in the execution. We have debugged. We've seen some of the issues that needed to be addressed and we now with full confidence will go into the pivotal study that if everything goes well, could start by the end of the year.

We're going to go into that trial armed with this experience in terms of execution and with confidence that our performance based on what we've seen in the pilot study will be such that it will meet our goals for the period. So all in all, super important that we have executed this pilot study and will be supplemented by the HEADSTART-ACS study in Jakarta, in Indonesia, that will have a similar number of patients with our pivotal study. So all in all, the pilot in Belgrade plus the current study in Jakarta is being executed will mean that we will go into the pivotal study feeling very good about the outcome.

Richard Ferrari

Yes, and on the other part of your question, I would say that probably the biggest learning from the initial work with the concierge practice is streamlining the workflow. You know, when we first were speaking to the concierge practices, you know, there's some hesitancy because they're trying to figure out how would this get implemented in the future to their patient population? What would be the best technique to do that? And also from our point of view, we wanted to make sure that we had a truly robust end-to-end system in terms of the collection of the information, the reading service, you know, and the feedback. So what we've learned from that experience is that we're going to be able to do that. That the best way to go about it is to do what Tim had just referenced, which is the intake criteria. We get alignment with the concierge practice that all patients that are coming in for intake will get a 12-lead EKG, and that becomes a baseline for the HeartBeam. And then if that particular patient is a patient that has concerns, you know, about their cardiac health or the physician concerns, thinks that they should in fact have the HeartBeam card, the card then gets deployed to them. So that's really the biggest learning is to get more embedded into the workflow. It's easier, more streamlined, and faster adoption overall, as you might imagine.

Kyle Bauser

Sure. No. Okay. Excellent. Well, thanks for all the updates and for taking my questions.

Operator

Once again, if you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. This now concludes our question and answer session. I would like to turn the floor back over to Richard Ferrari for closing comments.

Richard Ferrari

Again, thank you everybody for joining the call, really monitoring and watching what we're doing with HeartBeam. I can't say it enough. The opportunity that we have in front of us is truly enormous. The technology that we have developed is proven, it's accurate, and it's making a difference in patient lives. And it's going to make an even bigger difference in patient lives once we get through the FDA on the heart attack detection, because we will be the first to have sort of pioneered that approach with a handheld device or a wearable i.e. patch device that can in fact detect a heart attack. So we're really very, very excited about what we're doing. I know that many of you want to see revenue increase faster. So do we, but there's a process that all companies go through as they are pioneering completely new technology in a completely new area.

But we are very confident in what we're doing. The results speak for themselves in terms of the clinical data, our IP protection, the feedback that we're getting from physicians, the excitement that patients get our technology have. So we thank you for your continued interest, and we look forward to updating you in the future.

Operator

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines and have a wonderful day.