Good morning. Thanks for joining us again at the 25th Annual Needham Virtual Healthcare Conference. I'm Mike Matson, and I lead the Med Tech and Diagnostics Equity Research team at Needham & Company. I'm pleased to introduce Pulse Biosciences. Presenting for Pulse today, we have CEO Paul LaViolette and CFO Jon Skinner. They're going to give a presentation on Pulse, and then we should have some time for questions at the end. If you do have any questions you would like to ask, you can submit them electronically through the Needham Conference website, or feel free to email them to me at mmatson@needhamco.com. With that, I will pass it to Paul and Jon, and I will come back at the end to facilitate the Q&A.
Thanks so much, Mike. We appreciate the introduction and the invitation to join you and the team here at Needham. Good morning to all. It's a pleasure to present on behalf of Pulse Biosciences today. As mentioned, my name is Paul A. LaViolette. I'm the Chief Executive Officer, and I have been in the med tech industry now for over four decades. I've had an opportunity to work on many impressive and important, and disruptive technologies. Certainly, my observation is that Pulse Biosciences is at the top of that list, bringing extremely unique and proprietary nanosecond pulse field ablation energy to the field of electrophysiology and to a number of ablation targets thereafter. Jon, if we could go to the next slide. We'll be making forward-looking statements today, and here is our claim on that regard. Then next slide on our mission.
We're very focused on three key points. First and foremost, our exclusive mindset in and around the development of nanosecond pulsed field ablation energy. This is a very novel energy in the pulsed electric field domain. All of us have seen the impact in the last several years of PFA, pulsed field ablation, in particular the field of atrial fibrillation management. That's a very large, fast-growing, prominent marketplace. We'll talk more about that. Pulse Biosciences is the developer and owner of a range of technologies and intellectual property supporting a very novel form of PFA energy, and that is our exclusive focus. We'll spend more time talking about how we're developing that clinically and over time in different market applications. The second point to make is our conviction about rigor in development.
The company has been in existence now for over 10 years, has been investing aggressively in the development of this energy form. It has developed a massive trove of pre-clinical evidence and has now moved into multiple clinical trials and clinical segments, developing very important scientific evidence about the effects of this novel energy on tissue and on treating patients with chronic conditions. We're very focused on generating data. I think we've generated more data than would typically be expected for a company of our scale, and I think you would say the same thing about our intellectual property estate, which we'll talk about as well. Then lastly, I really want to talk about our ability to impact patients and the marketplace and all of its constituents, including providers and physicians and ultimately payers.
We have a very strong, I'd say visceral, commitment to our mission clinically, and we know that if we do the right thing technically, clinically for our physicians, for our patients, that we have an opportunity to be very successful in creating value for our shareholders. We have a very, I think, high order mission, and based on our track record, I think we've demonstrated that we're very capable of delivering on these goals. Next slide please, Jon. On the team, as I mentioned, I've been doing this for a number of years, both as a large company operator, a CEO, and a private equity investor, all in med tech, with a number of wins, a number of major market launches, and my view is that Pulse will be the capstone of that long career.
This company is really founded on an exceptionally strong technology base, and that technology base is led by Darrin Uecker. Darrin is our Chief Technology Officer, has really been with the company since its founding and is principally responsible for the direction of the technology and the conversion of that technology into clinical practice. Jon joined me just a year ago as Chief Financial Officer, as we've, I'd say, increased our public company presence. Let me spend a minute talking about two important new additions to the team. Liane Teplitsky has joined us only in the last week as Chief Operating Officer. Liane has a very pronounced career, a number of years in electrophysiology as a technologist, developing hardware as a sales executive, first at St. Jude and then through to Abbott.
Moved on to become a general manager at Zimmer Biomet, a Chief Executive Officer for early-stage med tech companies. Liane joins us as we scale our efforts in execution and as we shift our focus increasingly toward the effective execution of our EP program. Her deep background in EP, her fantastic track record as an operator joining this very strong team is a perfect addition at the perfect time. I also want to highlight, as I have in the past, the strength of our Chief Medical Officers, but most importantly today, Dr. David Kenigsberg, whom many know as a key opinion leader, electrophysiologist, and most recently as our part-time Chief Medical Officer, has joined the company on a full-time basis, of course, coincident with the launching of our IDE clinical trial in the United States.
We're very pleased to have this new extremely potent combination of Liane and David joining our ranks. Lastly, our board of directors remains remarkable and a secret asset, if you will, for the company. I've mentioned previously Maria Sainz joined us most recently. Maria also a very experienced operator and CEO in med tech and most notably, a recent member of the board of directors of Shockwave up through its sale to Johnson & Johnson. Maria brings fantastic perspective, governance, and operating experience. Of course, Bob Duggan is our North Star. Bob, a legendary investor and entrepreneur, had the vision to back Pulse Biosciences 10 years ago. Bob has been remarkably successful both in med tech and in biotech, and his daily interactions with us bring inspiration, operating insight, and energy that is unmatched. Next slide, please.
As we think about just our current financial snapshot, we ended 2025 with approximately $81 million of cash. We had $54 million of cash utilization in 2025, or approximately $15 million a quarter. We've indicated that for 2026, that burn rate will increase slightly as we intensify our operating activities with the performance of an IDE, both in cardiac surgery and in EP. Our burn will increase throughout the calendar year, peaking later in the second half of this year as we peak our clinical enrollment activity. We have adequate capital to perform all of our objectives for 2026, and we're very pleased to have the financial support both of our insiders and the capability to execute the game plan that we have, which is exceptionally exciting. Jon, next slide, please.
Let's just talk for a minute about Nanosecond PFA and energy forms overall and the market for ablation technology. I think everyone is aware that ablation emerged over the last number of decades as a means by which to treat tissues without surgery and to really drive the creation of minimally invasive therapies, and those therapies span all forms of conditions, targeting different organs across the full range of the body and in chronic disease. Thermal ablation takes tissue out with extreme temperature. More often high temperature, but you're also aware of cryoablation on the low-temperature side. This can effectively destroy unwanted tissues, but does so first and foremost by ablating, I'll say, everything in its path. All tissues, be they cellular, non-cellular, connective tissue, vessels, nerves, everything is ablated in the field of that thermal zone.
That thermal zone is difficult to control, and therefore there is an inherent safety risk associated with introducing and applying very high temperatures to a targeted zone, and then potentially incurring the risk of having that therapeutic zone reach beyond and touch on areas that should be protected. There are basic limitations to thermal ablation, although it is used tens of millions of times. Along came, in 2023, the first application of pulsed electric fields. Pulsed field ablation was introduced at the end of 2023, and through 2024 and 2025, we saw it have a dramatic impact on conversion of radiofrequency thermal ablation in electrophysiology over to a non-thermal application. This first generation of PFA demonstrated the potential for what PFA can do to therapeutic markets. There are limitations, however, to first generation PFA.
It is generally referred to as microsecond PFA, so the pulse durations of those pulsed electric fields are measured in fractions of a second, and those pulses in this first generation technology are relatively long, and they affect the cell by introducing permeability in the cell and causing those cells ultimately to die. There is a careful balancing act between the non-thermal and thermal boundary of PFA. In order to stay non-thermal, first generation PFA requires relatively limited delivery of total energy, relatively limited footprint of ablation zone, and often a lot of catheter manipulation and overlapping and stacking of lesions in an effort to create a more comprehensive ablation area based on the limitations of those first-generation pulses. Now let's move to nanosecond PFA. First and foremost, this is an energy that benefits from the pulsed electric field value.
It is intended to be entirely non-thermal and to ablate cells using electroporation. In addition, it's a far more efficient way of delivering energy. As a result, by collapsing the duration of the pulse by as much as 1,000-fold from a microsecond or a millionth of a second to a billionth of a second, we give ourselves the potential to dramatically alter the overall energy parameters delivered. Offsetting the extreme shortness of that duration, we add additional pulsing energy in the form of a higher amplitude, and that higher amplitude plus that extremely short duration provides us a very unique formula for delivering pulsed electric fields that allows us to deliver energy more efficiently, deliver it over a broader surface area, and deliver it in a workflow that is unmatched by any first-generation PFA. Next slide, Jon, please.
When we think about the novelty of that technology, it's important to understand that first generation PFA, as practiced today by multiple competitors, for instance, in the electrophysiology field, that first generation PFA is clearly relatively open source because multiple companies already sell it within the first few years of its introduction into the marketplace. What's really differentiating about Pulse Biosciences is that Pulse Biosciences has gathered and created all of the technologies necessary to generate and deliver nanosecond pulsed electric fields at high energy from the generator down through connectors into catheter systems, out electrodes, and into the tissue. We have a very extensive patent portfolio covering multiple facets of the generator, the delivery systems, and all technologies necessary along that continuum of pulse delivery. Which allows us to believe that we will be the sole company participating in the nsPFA category on a go-forward basis.
With that potential, let's turn our sights on the next slide to our commercialization and market access strategy. First up for us is the electrophysiology market treating atrial fibrillation. Everyone understands AFib is the number one most commonly diagnosed cardiac arrhythmia, and it is growing. It is growing rapidly because of the demographics, because of the health of our population, because of the presence of earlier diagnostic tools, and because of the prevalence of early ablation capabilities to treat early-stage AF, known as paroxysmal AF. These elements combine to create an extremely attractive $3 billion U.S. catheter market and a multibillion-dollar larger worldwide catheter market and overall AFib market.
When you think about diagnoses, this is multiple millions of new diagnoses per year, and the most important, I'd say, attribute of this market is that it is highly amenable to new technologies, and we've seen this market really be upended in the last 24 months based on the introduction of a PFA technology that offers speed, workflow ease, efficiency, safety, and really, as of yet, no improvement in efficacy. With that, Jon, let's look at the second or the next slide and talk about how nanosecond PFA can change that once again. Nanosecond PFA is known and demonstrated in our large data set so far, particularly the acute data set for lesion quality and speed.
We are capable with our energy efficiency of delivering only a single lesion where a competitive technology, let's say, the market-leading PFA technology from Boston Scientific, the FARAPULSE technology, that technology would be required to deliver four or five or six lesions in a given location to create a circumferential isolation. Our energy is capable of delivering a fully transmural lesion in five seconds with one application of energy, and that fundamentally redefines the workflow of the procedure. You see that evidenced in that finite element analysis image on the upper right-hand side where you see that red band. That's an example of a fully transmural energy wave being delivered through, in this case, that conical zone, which would represent the ostial area of a pulmonary vein. Speed is our differentiating factor.
We have the ability to deliver fewer lesions, five seconds apiece, and so total ablation time can be as low as five-seven minutes for these procedures. Workflow is enhanced dramatically. If you look at the catheter on the upper right-hand side, the zone between those two rings is the entirety of our ablation area. On each of the five arms that supports those rings, you see multiple sensors. We have the ability to map and ablate with the same catheter. We have the ability to ablate large footprint zones. We have the ability to minimize sedation areas because our pulses are in the body for so short an amount of time that we ultimately envision this technology being ideal for a shift in site of care from the hospital into the ambulatory surgery center.
Overall, this is an exceptionally timely and, I'd say, ideal market fit technology in the EP ablation space in 2026 and for the next five-10 years. To support that, we're enrolling our IDE now. We'll talk about that a little bit more momentarily. Next slide, please, Jon. I just want to bring this a little bit more to light, and then we'll go into the details. On the left here, you see an animation. On the right, you see a fluoroscopic image essentially representing the exact same placement of that catheter. As simple as this appears to be, you enter the left atrium, you enter one of the four pulmonary veins, you place the catheter into the vein. Those arms invert into that mushroom configuration. The two electrodes create a bipolar zone.
Five seconds of energy delivery between those two electrodes, and you have a single transmural contiguous circumferential ablation of that pulmonary vein. You then pull the catheter back to the antral position at the mouth of the vein, repeat that same five-second ablation, and if you think about it, enter the vein, ablate for five seconds, manipulate the catheter, ablate for five seconds. Really, you're treating an entire vein in under one minute. Given that there are four veins and it takes a little time to move from one to the next to the next, you can imagine how we land on our five, six, seven-minute total ablation time outcomes. It's really unprecedented in this space and has the potential to increase the treatment potential of the market, increase the efficiency of every trained electrophysiologist, and the throughput of every lab.
This can really be a dramatic upending technology in the AFib space. Next slide. As I mentioned, unprecedented workflow and speed, and ease of use have been enough so far to change the marketplace. However, we have much more to offer than that. We now are in possession of long-term follow-up outcomes that for the first time indicate that a new energy, in this case, nsPFA, has the potential to improve long-term clinical success. On the left-hand side here, you see a chart of data presented at the AF Symposium in February. In the middle column, you see the most representative data set for our technology, which represents a five-second data set treating patients with paroxysmal AF.
At the bottom, highlighted, you see that at 12 months following the same endpoint used by pivotal studies in the U.S., which is to say 24-hour Holter monitoring to detect AF, we had a 96% success rate, which is to say 12 months freedom from atrial fibrillation off anti-arrhythmic drugs and not having required cardioversion or a rhythm control implant. On the right-hand side, another look, potentially even more influential, which is all atrial arrhythmias, flutter, fibrillation, tachycardia, measured by all forms, including not only six- and 12-month Holter monitors, but also weekly telemetry monitoring using in-home ECG monitors. This shows 90% freedom from all atrial arrhythmia throughout the course of that 12 months.
Obviously, both the 96% AF freedom and the 90% Kaplan-Meier curve result of freedom from all arrhythmias are substantially improved upon any real data set ever demonstrated in the catheter ablation space for AFib. Next slide, please. We mentioned about a month ago that based on the compelling nature of these results, we were going to increase our emphasis on EP among our other programs, and so that emphasis comes in the form of investing to accelerate our IDE. Important to that, as I've already mentioned, are the additions of Liane and Dr. Kenigsberg to our leadership team. We have previously described our IDE as having started now in April and expected to be completed in enrollment by the end of the year. Throughout the course of this year, we'll update you on that progress, but our goal is to accelerate that with increased focus.
We also intend to continue to expand our clinical evidence using the feasibility study in Europe. Our goal there is to continuously broaden the data set, and importantly, because of the open label nature of the study in Europe, continue to provide follow-up data on a kind of a real-time basis throughout 2026 so that we can see more and more data accumulate for longer and longer periods of follow-up, validating with increasing concreteness the quality of our long-term outcomes. Lastly, we'll talk a little bit in a minute about our increased intensity of product development. On the next slide, just a little bit more detail on the IDE. As announced earlier this week, we have performed our first patient in St. Bernards Hospital in Jonesboro, Arkansas. Very successful first day. Seven patients treated.
I think this highlights the nature of the NANOPULSE study and of the Epicenter catheter from Pulse Biosciences. This is a first-time operator, obviously very experienced overall in AFib ablation, but first time utilizing the catheter. One roll-in patient followed by half a dozen study enrollments, all done in the first day. This would be a remarkable day in any lab using any technology, but to do it first time with a team that has not used this technology before highlights the speed and alacrity with which labs will be able to use the Pulse Biosciences technology to transform the efficiency of ablation delivery in the future. Next slide, please. When we think about our technology development goals, the image on the left, that light blue circle, that's our current device.
That is the device entering the IDE, and it indicates that the ablation zone is the area between the circular electrodes. That is very large. We'll call that a regional ablation footprint, and that provides tremendous operating capability in the lab. Then we also had developed a focal catheter, which is a way of delivering the same pulsed field ablation energy on a point-by-point basis. To make it abundantly clear, the best of both worlds would be to have those two energy delivery capabilities in a single delivery system. A single catheter will be able to deliver both a regional ablation zone and a focal ablation-targeted lesion without having to change catheters. Because these catheters also have sensors to map, you can imagine a single catheter capable of doing regional or focal ablation, capable of doing ablation and mapping.
A single catheter workflow could allow you to ablate the veins, move around the atrium, perform extra venous lesions, and perform the entire procedure without changing devices. We think this is the kind of innovation that has the potential to really upend the entire AFib ablation market. Next slide, just a closing couple of comments on the rest of our platform. As you are aware, nsPFA has the potential to go in many directions. We're very pleased to have commenced an IDE enrollment for cardiac surgery. Cardiac surgery, of course, in this case is also treating atrial fibrillation in the manner of concomitant ablation. When a patient with AFib is undergoing some other form of cardiac surgery for coronary bypass or valve repair or replacement, if they have AFib, it is guideline directed that those patients should also receive ablation to treat their AF.
That presents a significant market opportunity, and most importantly, that market today is served by only radiofrequency technology. With the advancement of our platform into the IDE stage, we have the potential to redefine that market and also to be the first PFA entrant into that category. We're very pleased with the data that we've seen so far and also have the objective of enrolling this IDE study in 2026. We also have an array of soft tissue organ ablation targets that are already FDA cleared, the first of which is for thyroid. We're in the market development phase of that technology. Thyroid disease, focused initially on benign thyroid nodules, represent the cause of as many as 150,000 surgical removals of the thyroid every year in the United States.
We think that represents a significant opportunity for a minimally invasive alternative using nsPFA in the thyroid to ablate nodules while leaving the thyroid functioning and in place. The ability to offer a patient a thyroid-sparing alternative to thyroidectomy, we think is compelling, and we're working on data reimbursement, an expanded FDA label to bring that technology to the fore. We also have a number of other indications. We're trying to stay very focused. We're prioritizing EP, but we're extremely enthusiastic about the downstream benefits of this technology, particularly in cancers. We announced a strategic relationship with MD Anderson and the initiation of our first clinical trial treating papillary thyroid microcarcinoma, and we believe that will be a study also enrolled in 2026 and the first of many breakthroughs for cancer patients leveraging this technology. Next slide, please.
Just wrapping up, here you see a summary of our activities, if you will, for the year. Principally highlighted by the electrophysiology study, perform the IDE, continue to release data, continue to advance our data generation in Europe, and continue to advance our R&D platforms. Then, of course, as I've just mentioned on cardiac surgery, enroll that IDE and on the soft tissue ablation side, continue to generate evidence to advance the reimbursement and regulatory prospects of that business while treating in a very pilot sort of way commercial patients who would prefer to have nsPFA rather than to lose their thyroid to a thyroidectomy. Then a closing comment, then I look forward to answering questions. This is an extremely compelling story. Nanosecond PFA both capitalizes on the benefits of pulsed field ablation while redefining the energy fundamentally.
We have a growing body of evidence to demonstrate exactly how compellingly different nsPFA is from precedent microsecond technology platforms. As mentioned, this is proprietary. We own a very vast estate of IP that would make it very difficult for anyone else to replicate our technology. We have a growing level of evidence demonstrating clinical benefits of this energy platform. The goal for this year is to drive more data, both leveraging the data coming out of Europe and then supplementing that with our IDE data. We have a number of markets that we're targeting, the most compelling of which, and first up, if you will be that very attractive EP ablation market for AFib with a number of indications that we're pursuing already to follow on.
We have the capital in hand in 2026 to execute on that plan, and we're very pleased with how 2026 is shaping up so far. With that, Mike, I'll end my comments and look forward to answering your questions.
Yeah, thanks. I guess first starting with the catheter business or product. You announced the pivotal trial. Can you maybe just talk about the design of the trial and how it compares to the other prior precedent trials from your competitors?
Yeah. The trial is a single-arm study enrolling paroxysmal patients, treating them with PVI or pulmonary vein isolation. In that regard, it's a relatively straightforward application of energy for a very large patient population. By that, I mean to imply very high flow of patients and should enroll on a site-by-site basis relatively quickly. We're approved to go to up to 30 centers, although we will probably not reach all of those by the time we complete enrollment. The N of the study, the target N, is up to 155 patients. That would generate data to be evaluated, if you will. The statistical plan is on 145, so we end at 145, but of course, if there are patients in the queue, we can exceed 145 and go up to 155. We'll enroll between 145 and 155 patients. That will be evaluable.
Each of the centers has up to two roll-in patients, which is how the number can exceed 155 and get up to 215. If you enrolled 155 plus two per 30 sites more, you'd add 60 to the 155. We'll ultimately enroll 145-155. The endpoint is focused on six months, but is, I would say, enriched by a portion of the patient population that will be followed by 12 months, and then we'll blend those two data sets using Bayesian analysis to end up with a 12-month endpoint, as predicted by a combination of six- and 12-month follow-up.
Okay. All right. Based on that, how much follow-up do you think you'll actually need? It's somewhere between six and 12 months, effectively. You probably can't really predict exactly where it'll fall?
Well, I think the way to think about it is the first patients through, who are earliest in the study, will be followed the longest, right? The first patients through will be followed for 12. If you think about enrolling 20, 40, 60, 80 patients, follow those patients for 12 months. The faster we can enroll the first tranche of patients, the faster we get to the point where we start that 12-month clock, if you will, and that becomes then the long pole in the tent. All patients after that would be patient number 75, patient number 100, patient number 125. Those patients can be followed for the shorter timeframe. The most important part is we're not starting a 12-month follow-up clock at the last patient in. We're starting that 12-month clock substantially before.
Now, of course, those patients that are being followed after we lock the data set and submit our clinical module to the FDA, we'll still be following those patients. In the end, the full study will follow all the patients to 12 months, but we don't have to submit on that. That will give us an advantage in timing overall.
All in, it seems like it's probably going to be 2028 before we see this approval. Is that reasonable or could it end up in late 2027? Is that possible?
There are three elements here. How rapidly can you enroll? How do we optimize that combination of six- and 12-month follow-up timelines? How rapidly does the FDA conduct its review? If you look at the optimal outcome of those three timelines stacked or sequenced, you can get to the end of 2027. As each one of those adds a little bit more time, you get to January 1, you get to the first quarter of 2028. I think conservatively, Q1 2028 would be our timeline. We're looking to have CE mark in the latter part of 2027 to initiate commercial potential prior to that. Importantly, of course, data will be flowing throughout. We'll be moving from a clinical kind of phase to now regulatory phase, but I think with regulatory certainty based on the quality of evidence.
I think the overall tangibility of our story increases significantly throughout 2027 with the penultimate approval from FDA at the end of that year or early in 2028.
Okay. What's your approach with regard to mapping? Does mapping need to be used? Are you going to try to make it compatible with kind of the change at CARTO and the Abbott EnSite systems?
Yes. Well, mapping, of course, varies depending on where you are in the world. In the United States, we're a very mapping-centric market, and mapping, in my opinion, can absolutely enhance the quality of the catheter management and the lesion locations for the procedure. I think most physicians feel that way. Improved mapping should make Pulse perform even better. That's our philosophy. As a result of that, as we announced in our press release, we have commenced the IDE using the Abbott EnSite mapping system. We call it a tight integration, so there's some proprietary software that is used to render our catheter, and yet our system will be approvable for all commercially available mapping systems and can be used in the IDE with all commercially available mapping systems.
Okay. I think we're almost out of time, but I have one final question. It was good to see that you're going to have a catheter where you can do kind of single-shot and point-by-point. What about RF capability? Because we've spoken to doctors, EPs, and it sounds like in some of the more complex cases, they prefer to use PFA, but sometimes they still want to use RF for some lines or some ablation. Are you going to have any ability to have RF on your catheter as well, or?
We have no interest in developing a dual energy platform. We think that is a compromise as a result of limitations in first generation PFA, and this is not something that we aspire to have. It is not necessary in our view with nsPFA.
All right. Well, I think we're almost out of time, so thanks so much.
Thank you very much, Mike.
Looking forward to your progress with the trials and commercialization.
Thank you.