HeartBeam, Inc. (BEAT) Earnings Call Transcript

Thank you. [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 today and webcasts may include predictions, estimates, and other information that may 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 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 of 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 hosts today, Richard Ferrari, Executive Chairman, Branislav Vajdic, founder and president, and Timothy Cruickshank, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2026. At this time, I would like to turn the conference over to Richard Ferrari.

Thank you, and thanks to all of you that have dialed into the conference call. Let me just walk you through the agenda very briefly. We're going to give you the progress on our key strategic initiatives, bring you updates regarding our cardiac platform and our heart attack detection, which is an incredible milestone that we've achieved this particular quarter, and then finally we'll close out with the financials. Next slide. Progress on the key strategic priorities. I think many of you that have been following the company will remember that in July of this year, we outlined our plan going forward and we organized focus on our core strategic priorities, which are shown on this particular slide. That was myocardial infarction (MI) detection, working closely with the FDA, working on reimbursement, enhancing the long-term value of the company through AI and other technological initiatives, and then on the financial side, cost efficiency and tight controls with respect to running the company. Now, when you look at heart attack detection, I have to say that in the last 90 days, Q3 was a fabulous quarter for achievement. And I think that's due to the focus that we have and the shift to the priorities that I have already mentioned. When you look at those achievements, these milestones are, for a small company, quite significant. Getting breakthrough device designation was something we were really going after and really wanted to count on. And just to give you sort of a reference point, the FDA, on average, over the last 5, 6, 7 years, only hands out about 164 of these designations. So it's a proof statement that the technology and the opportunity to enhance patients' lives is significant with respect to HeartBeam. That also enabled us to get enrolled, if you will, into their TAP program. Now, the TAP program is also quite significant because it enables us to have faster turnaround with our communications with the FDA. It also opens up CMS and payers so that we can have discussions with them regarding reimbursement and what are the needs that they need to see in our clinical trial to establish reimbursement. And then I think many of you may know that we had our publication and presentation at the TCT meeting at the end of October, which again, in our perspective, is the first study—it was 132 patients—first study to really look at, in an emergency room setting, a comparison between the gold standard of the last 50 years, the 12-lead EKG, and our handheld device for MI detection. And those results, Branislav will touch on a little bit later in this presentation, which were significant. I don't know that we've said this before. We did tell you that we were working hard with the FDA with respect to whether or not we would have a 510(k) or a de novo path, and we have a 510(k) path. That's significant because it streamlines our timelines with respect to ultimately getting approval to launch our MI initiatives. And then lastly, again, because of the TAP and the breakthrough designation, we are in constant communication actually with the FDA on our pivotal study. We've had a number of interactions with them. We are very confident in how we've structured that pivotal trial. And we're also very confident that we will get approval from the FDA very shortly on launching that trial and starting it, potentially this year, but certainly in Q1 2027. You know, on the reimbursement path, we have a reimbursement consultant we're working with. And as I mentioned to you, we will be in discussions with CMS and payers, seeing what it is that they need to have from us with respect to the clinical trial results or secondary endpoints that we might put in there that would enable them to go ahead and issue DRs or G-codes for the HeartBeam technology. So we're pleased with the progress we're making there. You know, in the long-term value and the AI side, we're going to touch on this in a minute. The market opportunity here, which you'll hear me speak about more, is just gigantic actually. And the beauty of HeartBeam's technology is that we can embed this technology in several different form factors, which I'll also review. And the real benefit of HeartBeam is its 3D technology. And you've heard me mention this before, that the technology we have is simply the best signal capturing and interrogation product that exists. Now, that's important because we're moving into utilizing AI to help further streamline technology. The richer data one has, the more valuable the information is. So we're really excited, and Branislav will touch on this, about our AI initiatives. And as Tim will touch on later as well, it's what we've been doing in controlling the costs and managing our cash appropriately. Next slide. So I'm going to walk us through the HeartBeam cardiac platform for you. So next slide, this slide really depicts I think the essence of what HeartBeam is dedicated to do. Patient delay in terms of getting to the hospital from the time that they have symptoms is the number one cause of death. And there is simply no device that a patient can have with them at their home, on vacation, or traveling that would enable them to determine whether or not they're having a heart attack. And if you look at the data on the left-hand side of that page, it's very, very revealing as to the damage that delay causes. Every 30-minute delay adds an 8.7% heart failure risk. This is a giant, obviously a big problem for the healthcare system. People that have congestive heart failure, they are repeat flyers in and out of the hospital at huge costs in terms of care and a 7.5% 1-year mortality. And again, at the bottom, a very costly approach to delays. So we're very, very excited about ALIGN results, as you'll see from the ALIGN study and what that means, and the fact that we're dedicated to really just improving how rapidly a patient has a symptom and can get to the hospital. And again, I'll just reinforce this: currently, there is no home ECG tool that reliably detects heart attacks. So the importance of getting to the hospital is paramount. Next slide. When you look at the core technology platform, now I've said this a few times this morning, but I'll say it again, the size of the TAM, the cardiac platform opportunity that we have, is simply one of the largest in the entire healthcare industry. A $40 billion opportunity affecting 50 million plus patients. And when you squeeze down on the specifics to heart attack detection, those patients that would be at risk, that's 20 plus million people. So once again, you can see the importance of having a device that was with you at all times, specifically if you had already had balloon angioplasty, cardiac surgery, atrial fibrillation procedures, coronary stents, or any predetermined risks related to your genetics in terms of heart health. So our goal is to close that gap between symptom onset and care by giving patients something that they can have with them and get an immediate response. It's a first-of-a-kind portable, cable-free EKG device. And it provides a clinical-grade report to a bank of cardiologists that read that information and then provide notification to the patient. On top of that, we have 25 issued patents worldwide incorporating our proprietary technology. And once again, the signal capturing and the ability to integrate the signal for us, the EKG signal, just opens up more opportunities for us going forward to further and further enhance the types of information we're providing to physicians, cardiologists, as well as to patients themselves. Next slide. I think you've also heard us talk about the fact that the technology is already proven. We've already built this technology. We have utilized it in a number of clinical trials. There's nothing more for us to build with respect to signal capturing and hardware. All we're doing now is enhancing it through AI initiatives. And because of that, we're capable of taking that technology and putting it into different form factors depending upon the application. So in this particular slide, you see the HeartBeam card, and that will be an item that someone carries with them. As you know, it's just roughly the size of a credit card. It will allow them to determine whether or not they have AFib or whether or not they're having a heart attack. The patch is a different form factor and addresses a different aspect of the model. It's targeted more for the inpatient step-down units where nurses are circulating and you may have an at-risk cardiac patient staying overnight or two. It'd be great if you had a patch on there where they said, gee, listen, why don't you put two fingers up and let's take a reading and see how you're doing. But of course, when they're discharged, we want them to go away either with the card or the patch, again, depending upon the specifics of that particular patient. And then we have what we call the HeartBeam remote unit, and this is, again, the same technology, but it's something that we're looking at in terms of outside the United States in more remote locations where towns or villages or what have you, who don't have tremendous access to the newest and greatest technology, would in fact be able to offer something to the people of that particular area that would provide, again, the type of information that's so critically important to their cardiac health. So, next slide please. So the heart attack detection and the milestones that we've achieved. Now, we've touched on this, but this is the roadmap going forward. So, when you think about HeartBeam, this is the way that you really should value the company. These next series of steps—and we're really proud of the team that we've got because they executed flawlessly in Q3 and they will execute flawlessly in my opinion on these next series of milestones. So we already know positive pilot study data, and Dr. Vajdic is going to touch on that. We have agreement with the FDA on the 510(k), and we indicated to you previously that we thought that's the way it would go. We are in constant communication with them regarding the pivotal study, mostly regarding the statistical model required, which drives the number of patients. We are, again, very confident in getting that approval with a study design and a number of patients that we can manage exceedingly well. I mentioned that, and I don't want to be overly optimistic, but it's possible we may enroll the first patient before year-end, but if not, we're very confident in Q1 2027. And again, based on the conversations we're having and the size of the trial that I think we'll be doing, we would expect the pivotal trial to likely be finished by mid-2027. And then after that, it's just simply compiling the data and providing that information to the FDA for clearance. And I can't give too much more information on the timeline related to clearance because a lot of that is dependent upon the start of the trial and the number of patients. But when you look at this, the singular word that should come to your mind is execution. We know how to execute and we know what is exactly required to deliver a green check in every single one of those boxes. We have a great relationship with the FDA. The breakthrough device designation and the TAP have really enhanced our ability to move through in a really expeditious manner. Next slide, and I'm going to turn it over to Branislav. Thank you, Rich. Actually, I'd like to emphasize two points. The first one is on the alignment with the FDA on our 510(k) pathway, which is a super important step. It clarifies the regulatory path for heart attack assessment, and it clarifies and we believe it shortens that path as well. Secondly, breakthrough device designation and TAP give us prioritized interaction and dedicated FDA advisors as we finalize the pivotal study design. We expect to complete the pivotal study design in the fourth quarter of this year. The interaction with the FDA—and I have been part of all these interactions—through the Breakthrough and TAP programs have been outstanding. The level of engagement and availability provide opportunities for us to iterate faster and provide us with an increased level of confidence. Now, let me walk you through the data behind this progress. Next slide, please. Earlier this month at TCT 2026 in San Diego, Dr. Graham Nicol of the University of Washington presented the results of our ALIGN-ACS pivotal study. The study enrolled 132 adults at the emergency departments of two major cardiology centers in Belgrade, Serbia. It evaluated diagnostic accuracy of the HeartBeam system compared with the standard 12-lead ECG in assessing acute coronary syndrome, which includes heart attacks as well. Eight cardiologists blinded to each patient's diagnosis independently interpreted both HeartBeam and standard 12-lead ECG recordings. The HeartBeam recordings were read with the support of a clinical decision support system. Their interpretations were compared with each patient's final diagnosis or gold standard. At the top level, we can say that the results showed that the patient-recorded HeartBeam 3D ECG was as accurate as the standard 12-lead ECG. HeartBeam showed higher specificity at 81.8% compared with 71.4% for the standard 12-lead ECG, with a comparable sensitivity of 60.2% compared with 63.0%—very similar, which points to its potential as a rule-in diagnostic aid. On the right-hand side, I would like to draw your attention to additional results of this study that are very encouraging indeed. The area under the curve, so-called AUC, is a measure of overall diagnostic accuracy. Actually, you can view it as a measure of information content found in our 3D 3-lead and standard 3-lead signals as well. The 3D 3-lead and the 12-lead showed the same area under the curve, the same AUC. This is a super important finding, and we'll be using it in finalizing our U.S. pivotal study design. Also, every patient in the study was able to successfully obtain a HeartBeam recording, which is a very encouraging sign for ease of use. For STEMI heart attacks, the most time-sensitive of all heart attacks, the sensitivity was 82.9% for HeartBeam compared with 83.8% for the standard 12-lead ECG—again, very similar indeed. The cardiologists also agreed with one another more often when reading the HeartBeam recordings, with a reader agreement score, namely Cohen's kappa, of 0.73 compared with 0.54 for the standard 12-lead ECG. As Rich mentioned, the results of this pivotal study will inform the design of our U.S. pivotal study, which is planned to commence in the first quarter of 2027, or possibly a little bit earlier if everything gets accelerated. As Dr. Nicol noted, these early findings demonstrate the potential of this technology to help shorten time to care for patients experiencing a heart attack. We want to say thank you to Dr. Nicol, all of our investigators, the patients, and all of the individuals that helped support this important study. Next slide, please. HEADSTART-ACS is one of our growing bodies of clinical evidence. In October, we completed enrollment ahead of schedule in our HEADSTART-ACS study, the largest heart attack detection assessment study to date using HeartBeam technology. The study was conducted in Indonesia, a country of 288 million people spread across thousands of inhabited islands, where many patients are unable to readily access a 12-lead ECG if symptoms occur. The study enrolled 486 patients presenting to the emergency department with chest pain at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia. Data analysis is underway, and we anticipate presenting the results at a cardiology conference in 2027. Together with ALIGN-ACS, we now have clinical experience with more than 600 patients in heart attack assessment. Next in line are our U.S. pivotal study plans, again planned for the beginning of 2027. It will support our FDA submission for heart attack assessment. In October, we also joined the EU co-funded EXIT-CVD research consortium as a contributing partner alongside Philips, Medtronic, GE HealthCare, and other global healthcare organizations. HeartBeam will lead the HEART-CHECK study, one of the project's 22 clinical studies examining high-risk patients. These studies are expanding our body of clinical evidence in heart attack assessment and are an integral part, actually, of our heart attack detection commercialization plan. Next slide, please. Alongside the clinical and regulatory work, we are building the path to payment for our heart attack assessment product. I will highlight three areas. First, our acceptance into the FDA TAP program provides us with early connection with CMS, payers, patients, and provider organizations as we build real-world evidence and assess coding, coverage, and payment pathways. Breakthrough device designation is also a prerequisite for certain expedited Medicare coverage pathways. Under the proposed rapid pathway, CMS would issue a proposed national coverage determination on the same day an eligible breakthrough device receives FDA clearance. The rapid pathway is proposed and not final yet, and we are actively evaluating how it may apply to heart attack assessment. Second, new CPT codes are emerging, including a recent category III CPT code for algorithm-assisted ECG analysis to identify heart attacks. This is an encouraging development, and of course, coverage and payment decisions by CMS and payers are separate and still ahead. Third, we are building supporting evidence of our impact on reducing the time from symptom onset to first medical contact. We are working to determine endpoints related to reimbursement for a heart attack assessment study informed by our early engagement with CMS and payers through the TAP program. Next slide, please. I will finish with our AI program update, which builds on the same 3D ECG platform. Our dataset includes more than 168,000 ECGs for heart attack training and more than 2,100 HeartBeam device recordings for testing. We finished development of our arrhythmia AI model, and our full attention and focus are now on the heart attack assessment AI model. In early internal analysis of HeartBeam recordings, the AI identified more heart attacks than physicians reading the same recordings. Positivity for our AI was about 12 percentage points higher across all heart attacks and 19 percentage points higher for non-ST-elevation heart attacks, with similar specificity. These results are very encouraging; yet, they are early, internal, and not yet peer-reviewed, and the HeartBeam AI remains investigational and is not FDA cleared at this time. Our initial atrial flutter algorithm, developed in collaboration with the University Hospital of Basel, Switzerland, showed 97% accuracy compared with electrophysiology study in 600 recordings using standard 12-lead ECGs. The network was presented as an abstract at EHRA 2026 European Conference, published in Europace, and the full manuscript has been accepted by the Canadian Journal of Cardiology. We are also collaborating on AI applications with Mount Sinai Hospital in New York and University Hospital Basel, Switzerland. Let me conclude by emphasizing our overarching goal to shorten the time between first symptoms and the decision to seek medical care. We aim to achieve this by providing patients and their physicians with clinical-grade cardiac information, knowing every minute matters. We believe HeartBeam can help close the gap for the millions of people at risk. With that, I would like to hand it back to Rich.

Thank you, Branislav. In fact, the next slide actually tees up Tim on the financials.

Great, thank you, Rich. Thanks, Branislav. Those are great updates. Taking a look at the Q3 2026 financials, we'll focus in on cash flow first. Net cash used in operating activities was $2.6 million in the quarter. That's a 23% decrease in operating cash outflow compared to the second quarter of 2026 and an 18% decrease compared to the same quarter in the prior year. Last quarter on this call, we walked you through the step-down in cash flows that we expected to see, focused on getting baseline Q4 2026 operating cash flow to below $2.5 million. We're happy to report that that's tracking as planned and, in fact, ahead of schedule a bit, and I'll have some more on that in a moment. Total operating expenses were $3.5 million, down 32% compared to Q2, and down 35% compared to the third quarter of last year. Major drivers were R&D being down $1.2 million from last year's third quarter. $0.8 million of that came from the completion of product development and related consulting costs for the HeartBeam system and prototype patch, as Rich called out earlier. Development is broadly complete, so we're seeing a decrease across the board there. Another $0.3 million came from completing the ALIGN-ACS pilot study, and a further $0.1 million from lower employee costs. For the SG&A portion, that's down $0.7 million, driven by $0.4 million of non-cash stock-based compensation decreases, and then $0.3 million from lower employee costs. The takeaway here on cash flow: the focus on our heart attack detection program is providing an opportunity for enhanced capital efficiency. I've talked a lot in the past about the variable nature of our cost basis, how it provides us a lot of flexibility in decision-making. We keep a very low employee base and we rely heavily on seasoned consultants focused on specific projects and objectives. And so when we determined it was time to go all-in on accelerating our efforts towards heart attack detection, we were able to not only quickly shift our capital allocation, but also reduce our overall spending significantly. And we're seeing evidence of that almost a quarter ahead of schedule. On the balance sheet, cash and cash equivalents totaled $6.1 million at September 30, 2026. That compares to $4.4 million at the end of last year. And since quarter end, we raised approximately $4 million of net proceeds through prudent use of our at-the-market facility. Total, that gives us a pro forma cash balance of approximately $10.1 million. As we look ahead, as we outlined in the previous quarter, we expect that baseline fourth quarter operating cash outflow to be below $2.5 million and are on pace for that. That pro forma cash that I mentioned, along with our continued efforts to reduce our non-core spending, is extending our cash runway further into 2027 and is aligned with achieving a number of key upcoming milestones. Accelerated timing of the U.S. pivotal study could potentially add to the $2.5 million cash outflows that we estimate for Q4, but that would be a welcomed expenditure if we're able to continue to accelerate that program. And for the full year 2026, we now expect net operating cash outflow between $12 million and $12.5 million, which is a further reduction from prior guidance earlier in the year of staying below $14 million. So we're pleased with the results there and seeing the cash numbers come in as planned. As we go to the next slide, turning to the income statement: SG&A was $1.3 million compared to $2 million in the third quarter of last year and $2.8 million in Q2. R&D was $2.1 million compared to $3.3 million last year and $2.3 million in Q2. Total operating expenses were $3.5 million compared to $5.3 million last year and $5.1 million in Q2. Net loss for the quarter was $3 million, compared to $5.3 million in the prior year quarter of 2025 and $5 million in Q2. So, across the board in SG&A and R&D, you're seeing evidence of the measures we put in place to enhance our capital efficiency, both in cash flow but ongoing in the P&L as well. While we've been working at it consistently over the past year, we really accelerated our efforts over the past quarter. And you get a good visual of the magnitude of our cost containment when you compare Q3 2026 to Q3 2025 there on the screen. So for the nine months of the year, operating expenses are coming in at $13.3 million versus $15.8 million, that's a 16% decrease in the nine-month period. Net loss was $12.7 million versus $15.7 million in the prior nine months, and cash used in operating activities was $9.5 million versus $11.1 million, a decrease of 14%. So as we look at that nine-month number of $9.5 million in net cash used in operating activities, you can quickly see the range of $12 million to $12.5 million for the full year and how that comes about with our anticipated spend of $2.5 million, and we've just buffered that for any acceleration we see in the pivotal study. In summary, the purposefully variable nature of our cost base really allowed us to pivot quickly. We are laser-focused on accelerating the path to FDA clearance for heart attack assessment, and you're also seeing evidence of those efforts in our milestones, but amazingly in our cash reductions as well. We're managing dilution to shareholders in one of the most controllable ways by reducing our non-core spend and really limiting our cash outflows. This capital efficiency is extending our runway and also aligning our spend with the achievement of our key upcoming milestones. So with that, Rich, I'll turn it back to you.

Yes, thank you. Our last slide is the summary and the key takeaways. We hope the slides that we presented today were clear, and there shouldn't be any question about the fact that heart attack detection is our top strategic priority going forward. We also hope that you can appreciate the significance of the HeartBeam technology and the significant market opportunity that lies in front of us. The team that we have is just really exceptional, and I think it's a credit to the leadership on a number of fronts by Branislav and our internal team. When I think about this going forward, when I think about what HeartBeam is doing, when I think about the importance of the technology in saving millions and millions of lives—and I think many of you have heard me say this before—we have a clear path over the next 12 months. We know exactly what needs to be done. We have great communications with the FDA. We're working on the really critical, important elements to drive shareholder value. And between now and the end of 2027, I would tell you there is very little risk in our path going forward; it is pure execution. And I hope that all of you can appreciate that we said that 90 days ago, and we've delivered on exactly every single element of execution that we have laid out, and we're extremely confident in the next series of execution milestones. So I'll stop there. And I think we're going to be going into questions, happy to answer as many of those as we can.

Thank you. [Operator Instructions] Our first question is from Jeremy Perlman with Maxim Group. Please proceed with your question.

Good evening. Thank you for taking my question. Firstly, you mentioned that you're finalizing the U.S. pivotal study design probably hopefully within this quarter. Is there any information you could share, maybe more details regarding what that study size might look like? What are some of the primary and secondary endpoints and the expected enrollment duration?

I can, yes, this is Rich. I will give you some points to that, and Branislav, maybe you want to end with a couple of points. But I can tell you that we haven't arrived yet with agreement on the size of the trial, but we've had very, very good conversations with the FDA. And we have a proposal to the FDA based on a statistical model from Harvard University, and I would give you the range that we think is most likely, probably around a 300-patient size for the trial. So, when you think about that, we'll have approximately eight centers, possibly 10 centers enrolling. And if you took a very, very conservative approach to enrollment—now remember, these are the top cardiac centers in the country—let's just use a conservative number that they enroll 10 patients a month. If it were eight centers... let's just use 10 centers and make it a lot easier, that would be 100 patients enrolled in the trial every single month. In three months, you'd be at 300 patients. So that's a rough estimate. Now, it may take us four months to enroll, or what have you, but the fact of the matter is, every other trial that we have in fact started enrolled faster than what we thought. So we do have, I think, a high confidence level. Our centers are excited, as Branislav had mentioned. The ALIGN-ACS basically is the proxy, if you will, for the pivotal trial. So we're very confident that we will get approval from the FDA, and like I said, it's a question of whether or not that happens before year-end or at the very beginning of 2027.

Yes, I would like to just supplement this. We have a proposal to the FDA now through this breakthrough program that is going to result in quite timely feedback. And it is, at this point, a very solid proposal. We believe it addresses all the concerns. But at this point, we cannot be sure really what the FDA reaction will be, inasmuch as we feel very good about what we are proposing to the FDA. Things may change a bit from what Rich has described, but we are very confident in the materials that we are submitting. Yes, you had also asked about the secondary endpoints, and I don't know that we've completely defined those yet as we're having these conversations, but we will in the final package.

Right. No, I understand. I understand it's still early, it hasn't been finalized, but I appreciate all that extra information. So maybe just segueing from that, the FDA regulatory pathway: what clinical evidence and performance thresholds, do you think, would be required from the FDA to get that 510(k) clearance? Branislav, go ahead and touch on that.

The ACS study that we just presented at the TCT conference is sort of mirroring the endpoints that we propose now to the FDA, right? And I described our results, and during those results that you have seen in my slide there, there will be endpoints that we propose. And again, the performance that we have seen in this pilot study is very encouraging indeed. And the pivotal study could be viewed as an enlarged version of the same design that we have tested now already in this pilot study called ALIGN-ACS.

Okay, I understand. And then, this may be the last question from me. Are there—I know you do have existing FDA clearance for arrhythmia detection—are there any opportunities to maybe monetize that existing clearance, you know, maybe through licensing or a strategic partnership where you wouldn't have to put in a lot of capital or resources behind it, but still be able to monetize it in some way?

Well, I think it's a great question. Our focus, as you've heard us say before, with the arrhythmia detection right now, monetizing it in a large way just simply isn't the focus. But we are quite frankly, again, working with, as we've mentioned before, a number of powerful concierge practices. They are putting units into the hands of patients. It's just not a significant event at the moment other than as a learning and understanding of the use parameters. Now, we've also had, as you might imagine, since the ALIGN-ACS data, we have had a number of folks who are interested in what it is we're doing and whether the technology may be able to be utilized in something they may be doing. But it's really too early to say. We're clearly open to those kinds of discussions, but at the moment, commercialization is just being modest, and we're testing the market and trying to understand reimbursement, trying to understand the use parameters, and understanding how physicians will, let's call it, prescribe our product to their patients.

Okay, I understand. That makes a lot of sense. Again, thank you for taking my questions. I'll hop back in the queue.