Pulse Biosciences at Needham Conference: Strategic Growth and Market Expansion

On Thursday, 10 April 2025, Pulse Biosciences (NASDAQ: PLSE) presented at the 24th Annual Needham Virtual Healthcare Conference, showcasing its strategic vision and technological advancements. The company highlighted its strong financial position, innovative technology, and ambitious market targets, while also acknowledging the challenges of increased operational costs as it moves towards commercialization.

Key Takeaways

• Pulse Biosciences is focusing on its nanosecond pulse field ablation (NSPFA) technology, with potential applications across various markets.
• The company holds seven FDA clearances and over 180 issued patents, with another 100 pending.
• It aims to target a $6 billion market, potentially expanding to $15 billion in the coming years.
• Pulse Biosciences maintains a robust cash position of over $100 million, with a projected burn rate increase due to commercialization efforts.
• Commercial activities for benign thyroid nodules are set to begin in 2025, with significant clinical trials planned for cardiac surgery and electrophysiology.

Financial Results

• Cash position: Over $100 million at the end of the fourth quarter
• Historical burn rate: $36 million for 2024
• Cash runway: Expected to last over two years, even with increased expenses

Operational Updates

Benign Thyroid Nodules

• Commercialization to start in 2025
• Completion of a 10-center, 100+ patient clinical study
• Expansion plans from 10 centers to over 40 by the end of 2025

Cardiac Surgery (Preoperative AFib)

• Development of a surgical clamp for open heart surgery
• Breakthrough designation from the FDA and participation in the FDA's TAP program
• IDE pivotal study to commence in mid-2024

Electrophysiology (AFib Treatment)

• Development of a catheter for circumferential and transmural tissue ablation
• IDE submission planned for mid-2025
• Positive clinical experiences in Europe with reduced ablation times

Future Outlook

• Pursuing a hybrid business model with direct commercialization and partnerships
• Focus on thyroid nodules, cardiac surgery, and electrophysiology markets through 2026
• Exploring expansion into malignancies, starting with thyroid indications

Q&A Highlights

• No plans to integrate RF technology into catheters
• Single-arm catheter ablation trials against objective performance goals
• Randomized trials for surgical clamps comparing ablation to non-ablation
• Potential expansion into non-cardiac applications, including cancer treatment

Pulse Biosciences' strategic focus on NSPFA technology positions it as a key player in med tech markets. For a deeper insight, refer to the full transcript below.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Mike Matson, Lead MedTech and Diagnostics Equity Research, Needham and Company: Good morning. Thanks for joining us again at the twenty fourth day of Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research team at Needham and Company. I'm pleased to introduce, Pulse Biosciences presenting from Pulse. We have Paul LaViolet, Chairman, President, and CEO and John Skinner, CFO.

They're gonna give a presentation on the company, and then we'll open it up for questions at the end. If you do have questions you'd like to ask, you can submit them electronically through the conference website, or you can email them to me at mmatson@neoco.com, and I will try to fit them in. So with that, I'll turn it over to Paul.

Paul LaViolet, Chairman, President, and CEO, Pulse Biosciences: Thank you, Mike. Very much appreciate our long standing relationship and your support of us joining this conference. As Mike said, my name is Paul LeViolet. I've a forty five year track record in medical devices. I joined the board of Pulse Biosciences last year and found the technology and markets and clinical potential to be extraordinary.

And in the process, decided to join as chief executive officer, which I did, earlier this year. And John Skinner joins me. John is our chief financial officer, and we're looking forward to sharing our story about the company with you and answering questions as we go. John, if we've already looked at the forward looking statements. Our mission is to solely focus on nanosecond pulse field ablation, and to harness it and deliver its therapeutic value.

This is a technology that offers an extraordinarily wide array of, chronic disease therapies. It has all of the newly learned, benefits of of pulsed field ablation that we're now beginning to see in the electrophysiology market to treat atrial fibrillation, but we have many additional and proprietary advantages based on our position in the nanosecond range of energy delivery, and we'll spend some time describing that. We believe we are in possession of a revolutionary energy form that has multiple clinical applications, and we're excited to be building out that platform, through the clinical stage and now entering the commercial stage in 2025. Next slide, please, John. I'd like to include a quote here from doctor Niv Odd.

Doctor Odd is perhaps the most published cardiac surgeon in the world. He also happens to have recently joined Pulse Biosciences as a chief medical officer, and, his view is that NSPFA has the potential because of the qualities of the energy and how it affects tissue to replace all other energy modalities in clinical use. And in the process, because of its qualities, adding speed, adding safety to procedures, enabling less invasive alternatives to surgery, every application has the potential to expand the number of patients treated in respective markets. So it has the potential to lower the interventional bar, increase market sizes and disrupt market position. So we're extremely, pleased by what we've seen with the technology, and doctor Add's commentary, we think, nicely characterizes the potential that Pulse Biosciences brings to respective markets.

Next slide, John, please. If you think about our current financial position as of the end of the fourth quarter, we were in a very strong cash position with well over a hundred million dollars cash on hand. We believe that provides the company with a multi year runway to execute our clinical trial strategy, as well as to scale our commercialization efforts in our first go to market initiative, which we'll describe that is a launch into a relatively new, but large and untapped market to treat benign thyroid nodules under as, or I should say as the first use case for our soft tissue ablation clearance. We have, in addition to the cash runway, a historic burn rate for 2024 '30 '6 million dollars We expect that burn rate to increase based on the activities that I just mentioned, commercialization and clinical support of several investigational clinical activities. However, with even with increased burn, as I mentioned, we expect our cash runway to, reach two plus years.

We have very strong investor support. I'll describe our board, in a few minutes, and, we're very pleased with our current position. We have the resources necessary to execute our near term business strategy. Next slide please, John. Here is a quick look at the team and I'll just spend a minute, further introducing myself.

As I mentioned, I've had about forty five years in medical technology, had about thirty years running businesses, including as chief operating officer of Boston Scientific, where I spent fifteen years helping to build that platform company. And in addition, have been a venture capital investor in medical technologies for the past fifteen years. So I have a very deep experience with new markets, exciting new technologies, all facets of the medical device industry. And I've seen a lot of very compelling technologies over time and find Pulse to be absolutely irresistible in that regard. We have a very strong team, Darren Uecker is our Chief Technology Officer has been with the company for a decade and leads our operations, research, clinical and regulatory teams.

Kevin Danahee, Mitch Levenson, Chief Commercial and Chief Strategy Officers, who are really defining our market opportunities and our market entry strategies. And then John Skinner, John joins me today. John recently joined the company as Chief Financial Officer. We're very pleased to have him and he's making a remarkable contribution, early in his tenure with the company. I think it's very important to highlight that we have invested in and added the experience of multiple, chief medical officers, all of whom are world renowned in their respective specialties.

And this I think defines both our conviction to have, clinically oriented development programs, but also describes I think the magnetic pull that Pulse Biosciences represents to leading physicians who find the clinical potential of nanosecond pulse field ablation to be irresistible and, for which they would love to have, a role and impact our, development and clinical strategies. We have a remarkable, board of, directors, led by Bob Duggan. Bob, of course, is a a legendary entrepreneur and investor, a serially successful builder of businesses. And with Bob, we have a team of individual business leaders who have been incredibly successful, and I will say are remarkably, for my experience, remarkably engaged in our business and we benefit greatly from their routine support. Next slide please, John.

Just a few minutes on the development of the company. We're now seeing, we all, in the medical device marketplace, the emergence of the use of pulsed electrical fields to ablate tissue, and that of course is defined now as pulse field ablation. That field has emerged clinically and commercially in the last several years, principally in the electrophysiology space, although this energy can be applied in many, many areas. And PFA has evolved itself. And I would characterize the PFA that we see in today's market as first generation.

And that first generation resides in the microsecond or one millionth of a second pulse duration category. And so nanosecond PFA changes that dramatically. We lower our pulse duration by an order of magnitude and with that change come many clinical and technical advantages, which we'll spend a few minutes talking about. As a company, we really are the byproduct of several decades of work, including a decade, twenty years ago, at the university and basic research level where nanosecond PFA was created. And then Pulse Biosciences over the just the past ten years or so, having invested approximately $400,000,000 to develop the technology in the first applications.

We're the beneficiary of over a thousand publications on NSPFA as an energy form. We have de risked the company by advancing our platform through development into the FDA clearance process, have achieved seven clearances, and our most recent device, which we'll describe in a minute, has also achieved a breakthrough designation with the FDA. So we really feel as if we are a young company emerging into commercialization, but with remarkable foundational strength that is reflected in a proprietary platform that is protected by over 180 issued patents with another over 100 pending. So a very proprietary system of delivering pulse field ablation energy from the generator all the way through to a series of applicators to treat multiple clinical indications. John, next slide, please.

Just to give you a sense of our market opportunity, the number of markets that we're currently pursuing, and how those create market potential for our team and for our company. We currently are focused on three areas, which I'll describe, and those three today invite the potential of about $6,000,000,000 of market potential for Pulse Biosciences to pursue. We have large markets today, but those large markets actually are growing significantly based on our ability to penetrate those markets, our ability to expand globally over time. We believe our addressable markets with our our addressable market potential with just these three categories will expand from the high single digit billions to the mid teens billions, 15 plus billion dollars over the next handful of years. That's based upon three, markets that I'll describe.

The first one is based on a soft tissue clearance from the FDA, the first use case of which will be to treat benign thyroid disease. And I'll spend a little bit of time talking about why that is such a, dynamic business opportunity and a remarkable, clinical application. Our second would be to enter the cardiac surgery market to treat preoperative atrial fibrillation. This is a very exciting market, it exists today, it is underserved technically by radiofrequency tools and it is certainly under penetrated as a result, and we'll describe that in a little bit more detail. And then lastly, but the largest of them all, the electrophysiology market to treat atrial fibrillation, We all in medical technology markets, we all see this as a dynamic new category.

It's been of course one of the largest interventional cardiovascular fields for a long time. The underlying incidence of atrial fibrillation is growing. The procedural rates and volumes of treatments are increasing at double digit rates and that this technology is undergoing really or I should say this market is undergoing a technology transformation with the, first the first arrival, if you will, of PFA, to treat, patients. And so our sense is that the this combination of markets provides us small, medium and large opportunities where we can create new market value, we can expand existing markets and we can up end current large entrenched markets. And we feel that provides the company with a wonderful array of commercial opportunities.

And we'll describe how we're going to go about that in just a minute. The next slide gives you just a little bit more of an overview about pulse field ablation. And, we're of course seeing and hearing and reading about PFA because of its impact on the EP space. And what we're really seeing is a transformation from the use of alternative hot or cold energies that destroy tissues, into a conversion, with the use of pulse field ablation to produce non thermal, tissue destruction. And this allows for the conversion of not only this particular field of EP, but really multiple fields where extreme heat or cold is used currently for the destruction of cells, we believe pulse field ablation has the potential to address many of those markets with better clinical outcomes while dropping right into the existing workflow currently used by interventional physicians.

So the result of faster energy delivery, the result of non thermal therapeutic potential allows for increased throughput, more procedures, increased efficiency in the healthcare delivery process, and importantly, greater, safety because we're not, introducing extremes that that propagate uncontrolled within tissue beds. So while we see great potential across multiple markets, we also have to recognize that today in the commercial application, what we see is really first generation of PFA energy and what Pulse Biosciences will be bringing is a next generation of pulse electric field application to multiple markets and with significant clinical benefits, we believe. Next slide, John. This just gives one more, view of what differentiates nanosecond pulse field ablation from current applications using microsecond. If we think about the engineering difference between these two, what we're really thinking about is dramatically shortening the pulse duration, which is to say how long that pulse exists in the tissue.

The shorter we can make that, pulse, the lower the likelihood that it will leave any heat, behind in the tissue. And with a reduced amount of heat potential, we can use higher amplitude in our waveform to produce greater clinical effect while remaining a completely non thermal, treatment. And we think this really produces substantial, clinical benefits and those clinical benefits translate over to, as I've mentioned previously, safety, and ease of use. The most important element of what, nanosecond PFA delivers, excuse me, is that it is it is non thermal. It can be applied to the tissue without raising the tissue temperature.

We believe our energy as a result of how it's delivered can produce deeper lesions, and in many cases we're looking, depending on the treatment application, to create a full thickness or transmural lesion to complete the most effective ablation. We can we also introduce an entirely new mechanism of action, which we believe will improve healing in patients and reduce what is left behind, if you will, in the form of scar tissue. And lastly, current PFA systems tend to deliver energy that is picked up by nerves and those nerves send that energy to the surrounding muscles, which cause patients to have involuntarily involuntary movement, during treatment, and that, can increase the, required anesthesia level, to paralyze patients and prevent, involuntary motion. NSPFA does not produce that same form of muscle stimulation, and that produces a significant upside potential for our application. In addition, by having a novel energy, we are allowed to create novel catheter forms.

Our catheters tend to be more flexible, easier, to use, more clinically friendly, if you will. And, all of that, creates a system from end to end that is proprietary, and clinically advantaged. With that, John, let's turn to the next slide and, just talk a little bit about how we manage the breadth of this platform opportunity. As mentioned, we're going after multiple markets, some of which are very large and entrenched, some of which are new. And, we are looking to bring as many applications to commercial stage as we possibly can.

And we realize that commercializing a platform of multiple markets is is very difficult for any company to do. So what we're trying to do is create a hybrid business model by identifying certain markets that based on criteria related to competitiveness or based on the magnitude of the entry barriers or capital efficiency of entering. We can enter certain markets with a direct business model, and then we will enter other markets that are larger and more complicated through partnerships. This hybrid business strategy allows us to pursue multiple markets while, preserving capital efficiency in our operating model and, still accessing as many patients and delivering as many therapies to the market as possible in the shortest amount of time. And with that, we'll go to the next slide and begin to talk about these market opportunities one at a time briefly.

The first market opportunity that we're pursuing, as I mentioned, is the thyroid benign thyroid nodule market. That is a market that is today supported by our first clearance in soft tissue ablation and will commence commercialization activity in twenty twenty twenty five. If we look at how this market, is constructed, what you see here is approximately a 250,000 per year patient diagnosis rate, and of that two hundred and fifty thousand, approximately one hundred and fifty thousand annually undergo benign thyroidectomy, which is to say removal of the thyroid in order to eliminate the symptoms associated with thyroid nodules. In addition to the one hundred and fifty thousand undergoing annual surgery, another one hundred thousand choose to avoid surgery, but really have no treatment alternatives, and therefore they go into a watchful waiting pool that has built up in scale over time to, in our estimates, to at least a 2,000,000 patient waiting group. So if you think about annual incidents and surgery conversion, you think about drawing from a large watchful waiting pool, we believe there is a very large patient population here that can produce a $1,000,000,000 market opportunity that Pulse Biosciences would uniquely pursue.

The real benefit here is to spare the thyroid, to preserve this critical gland that produces hormones controlling heart rate, body temperature, blood pressure, and metabolism. And today, those 150,000 surgeries remove that vital gland solely for the purpose of reducing symptoms from a benign growth. And so the the patients are understandably quite reluctant to have loss in that in that bodily function solely for the purpose of reducing the volume of a growth. And John, let's go to the next slide and talk a little bit about what this technology does. Nanosecond pulse field ablation can reduce the nodule size and spare the thyroid gland itself while not touching, not disturbing, not endangering the adjacent critical structures of nerves and blood vessels that closely surround the thyroid gland in the neck.

NSPFA, as we've talked about, is a non thermal energy, it does not introduce heat in this zone. It ablates the tissue without leaving a scarring effect behind, which unfortunately is caused today by current treatment forms. And we produce a significant symptomatic relief by reducing the size of the nodule, taking the compressive forces symptoms off of the patient's neck, and doing so without surgical intervention, and leaving behind, as you can see in these images, leaving behind a an area that, over time looks as if it never was treated and has has really been restored, to completely normal appearance and and most importantly, normal function of the gland. Next slide, John. If we think about the status of this, as I've mentioned, this is now fortunately for us, FDA cleared and we're beginning, to move into the commercial phase.

We're completing a 10 center, which is currently underway, a 10 center, hundred plus patient, clinical study to gather, evidence in support of, adoption and, reimbursement. And we're transitioning this program from early pilot stage, if you will, now into commercial. That transformation will take place throughout the course of 2025, and we'll begin to accumulate our first commercial experience with this platform in the conversion of those clinical centers over to commercial, and then the expansion of that commercial footprint from those first ten centers up to our target of 40 plus by the end of this year. So we're working to fortify claims, to build clinical evidence and really create a first mover, market for Pulse Biosciences in this very large and significantly underserved, market, and clinical population. Don, next slide.

The next, opportunity that we'll talk about is in cardiac surgery, and this is for the treatment of patients undergoing cardiac surgery for what could be a coronary bypass or mitral valve repair, and in whom atrial fibrillation already exists as a preoperative condition. So imagine a patient going in for open heart surgery and already diagnosed and suffering from AF. And so our job now is to find a way to treat those patients of their atrial fibrillation concurrent with the open surgery they're undergoing for their primary concern. This is a very large market, there are about three hundred thousand annual open heart surgeries, of which approximately a quarter or over a quarter, present, with AFib preoperatively. Despite, the treatment of these patients for AF being current guideline directed therapy, only about a third of those patients actually receive treatment in the form of concomitant ablation during their surgery.

And so this is the opportunity we believe we can both enter and then subject subsequently expand dramatically. The current market is about, 80,000 patients, but only, as I mentioned, a third currently receiving treatment. We believe that that low conversion rate of patient treatment is directly attributable to the limitations of current technologies, including principally radiofrequency ablation. And so in the process of converting RF to nanosecond pulse field ablation, we believe we can produce dramatic improvements in clinical effectiveness, drive utilization up, and really create a market that, first converts, to nanosecond PFA and then becomes a much larger market because the clinical benefits would drive increased utilization. And to look at our status, we'll go to the next slide.

Here you see that we're developing a tool that will be used in the image on the lower right hand side during open heart surgery. The surgical clamp that you see produces an energy field between those two edges and that surgical energy field produces a clean non thermal, very rapid, ablation zone that can, treat, atrial fibrillation extremely quickly, and speed in this instance is exceptionally important because these patients are on cardiopulmonary bypass, and as we all know, pump time is exceptionally, critical, and has to be kept to an absolute minimum. So the benefit here of NSPFA producing full thickness non thermal lesions, to allow, the completion of, ablation procedures, we think can be highly enabling to the fulfillment of the goal here, which is to treat AF in patients while they're on the table undergoing cardiac surgery. Next slide, John, to give you a sense of where this program resides, it is currently in a clinical phase. We've completed the first arm of our feasibility study.

We're seeing very compelling clinical evidence. We've used our evidence to date to apply to the FDA and have received breakthrough designation and are participating in the regulatory TAP program, the total product life cycle advisory program, which essentially provides us real time review with the FDA. This program will move into its IDE pivotal study in The United States in the middle of this year, and we have very high expectations for the clinical results that this will produce in the quarters ahead. And then the last one, next slide, John, is, the largest opportunity of all, and perhaps the most dynamic market today, and that is the, use of pulse field ablation to treat atrial fibrillation. It's the best, early example of, PFA's potential.

And while we're seeing a remarkable, dynamic and positive dynamic in the AFib market, I think it's really important to note that the clinical benefits of first generation PFA are limited, relative to existing RF ablation. Overall clinical efficacy is around equivalent, And while safety is beneficial, we think there is significant upside potential that next generation NSPFA can deliver in this market. You know about this category, it's extremely large, it's growing very rapidly, sustained double digit growth, exceeding $8,000,000,000 in time, multiple millions of patients and increasing diagnostic burden of AF in our population. So we think this is an absolutely vital area for PFA and one that represents significant clinical potential for Pulse Biosciences. So to take a look at our program on the next slide, you'll see how we're engineering a significantly different device that produces not spots of ablation, which current catheters produce, but actually full circumferential and transmural rings of tissue ablation.

This is a revolutionary delivery of energy, really substantially improves upon existing PFA platforms. This is a technology that would drop right into the current treatment workflow, produce deeper lesions, produce faster lesions, produce non thermal clinical benefits, and has the potential to be used, of course, during the core procedure of pulmonary vein isolation, but also to be used more broadly in the left atrium for a more diverse array of AFib patients. On the next slide, just to give you a little bit of a sense of how our technology would feel and work in the clinical application, we have only one catheter required to treat pulmonary veins and the left atrium. We can produce a single lesion in a five second burst of energy. We do not require multiple catheter manipulations or multiple catheter and electrode rotations.

So there's a significant reduction in the manipulation required by the physician. Total procedure time is dramatically reduced with ablation time dropping by two thirds down to just a few minutes, ten minutes, ten to twelve minutes is what we're seeing in our clinical cases. And because the nanosecond PFA does not capture nerves in the same way that microsecond, does, we are able to, treat our patients with lower anesthesia burden overall. So this is this this is potentially a very disruptive technology entering a market that has already shown its willingness to rapidly convert when a technology with disruptive potential is introduced. On the next slide, just a very quick anecdote, and then we'll wrap up.

This is an example of a first case done in Belgium a little bit earlier this year. This is a physician who had never used our system before, did not undergo a significant training, and produced pristine isolation in just a matter of eleven minutes or so. And this is this is supportive of, all of the clinical experience we're seeing across Europe. Very high isolation rates, very fast procedures, very little interventional and fluoroscopic imaging time, and we feel very positively about how this system will perform on a larger clinical base. On the next slide, you'll see where we're leading with this.

This program will also enter an IDE in the middle of twenty twenty five. We are going to be pursuing a conventional, and and now there are, of course, multiple companies that are pursuing this conventional paroxysmal atrial fibrillation indication. We'll be we we presented data and demonstrated a live case display at the Boston AF Symposium in January, we'll be doing very similar updates with new data and cases in the HRS conference in San Diego in in in later April. And as mentioned, we intend to be conducting our submissions and initiating the IDE for this technology in the in the middle of twenty twenty five. So we think this is an extraordinarily attractive technology application for NSPFA going after an exceptionally large market that is ripe for change.

And lastly, let me just conclude by summarizing and indicating that NSPFA is a novel energy. PFA is performing extremely well, but NSPFA produces improved clinical benefits and improved workflow, improved safety profile for patients and is a proprietary technology for Pulse Biosciences protected by over 180, issued patents and, nearly that amount pending. We have mounting clinical evidence across multiple, clinical indications. We are conducting multiple pivotal studies in 2025 and commencing our first commercialization launch. We have a strong balance sheet, a very strong team, an extraordinary lineup of market opportunities.

And we feel we're very well positioned to be a sole focused PFA player in multiple med tech markets going forward. And with that, I'll close my comments and Mike, I'll turn it over to you.

Mike Matson, Lead MedTech and Diagnostics Equity Research, Needham and Company: Yeah. Thanks. Wanted to follow-up on a few things. I guess first, you know, on the catheter ablation product, you know, as we've done work in the space, it seems like there's this view that, long term, there's going be a desire to have catheters that can maybe do RF and PFA with a single catheter as well as both offering catheters that can do focal ablation as well as single shot. I mean, it your view do you agree with that?

Is that something, you know, I know maybe you won't have that on day one, but is that something you could eventually incorporate into your your technology?

Paul LaViolet, Chairman, President, and CEO, Pulse Biosciences: I do not agree with that, and we would not incorporate RF into our technology. And I think it's really important to think about why anyone would do that and really it is in pursuit of lesion depth. And based on the proprietary, elements of nanosecond PFA, we achieve greater lesion depth, with our our higher amplitude energy delivery. And these are novel elements of our platform and would completely eliminate any need to consider integrating what I will now call antiquated RF energy into the generator. There would be no need to hybridize and complicate frankly the purity and the elegance of NSPFA with an RF energy.

I do agree that in addition, although the three sixty catheter tool that we have is exceptionally versatile, and we will evolve it to be even more versatile, There is value in having a focal catheter available, that is something that we are developing and is something that will be moving itself into human feasibility clinical work later this year.

Mike Matson, Lead MedTech and Diagnostics Equity Research, Needham and Company: Okay. And then just the trial designs for the surgical clamp and the catheter. So maybe you could just give us a quick overview there. Are those going to be there would you ever consider doing like a head to head versus the existing technologies with the FDA? I know when you get to sometimes when you get to a certain point where there's a lot of the products out there, sometimes they require head to head studies.

Just curious what your

Paul LaViolet, Chairman, President, and CEO, Pulse Biosciences: Yeah. So for the catheter, for endocardial ablation, actually, the protocols are relatively well established with FDA. They are single arm, studies, so non randomized, really just comparing to an objective performance goal based on published literature. They're actually not substantially large studies under two fifty patients enrolled to achieve a paroxysmal AF indication. The surgical clamp in effect is a comparative study, but it's randomized in in in general against non ablation.

Right? So you have an ablation arm, a non ablation arm, and you see how those patients perform. I have conducted many head to head studies over time. I think, in our case, we we're not looking to do that, certainly not in the near term. We think our clinical performance will be very strong.

We think the evidence will separate, if you will, even though it's not generated in a direct, you know, comparative design. And usually, head to head studies are done later in the market uptake of technologies like this. So if we were to do a technology to demonstrate our likely superiority against other platforms, we would do that later. But I think our evidence early on will be quite intriguing even in the absence of any direct comparisons within clinical trial designs.

Mike Matson, Lead MedTech and Diagnostics Equity Research, Needham and Company: Okay. And then just last question, you know, so you've got the in terms of non cardiac applications, you've got thyroid that you're going after, non thyroid lesions. So is there any other potential uses there? I mean, there because it could be used to treat cancerous lesions anywhere in the body, for example?

Paul LaViolet, Chairman, President, and CEO, Pulse Biosciences: Yes, great question. And the answer is yes to both. We do have, quite frankly, a building and long and impressive list of next clinical opportunities. We're very focused in 2025 and 2026 on the three that we've described here, although we will be expanding that list. And we will be describing to our investor base our strategic plan in the coming years and how those markets will be added to.

Malignancies, cancers are clearly within our mindset, and we are initiating in the latter half of this year some research to explore probably as an immediate adjacency thyroid indications. Remember our first application is benign thyroid, so our goal would be to try to assess, within that same clinical bed, within that same market channel, the same endocrine surgery operator base, whether we can expand to treat malignancies of the thyroid. That's something we're, in the very early stages of now, and we'll spend more time in the future talking about that.

Mike Matson, Lead MedTech and Diagnostics Equity Research, Needham and Company: Okay. Great. I think we're out of time. Thanks for coming to the conference. I hope you have some good news.

Paul LaViolet, Chairman, President, and CEO, Pulse Biosciences: Thanks very much, Mike. Our pleasure.

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