Conference Transcript - PLSE 2026-03-18

Suraj Kalia, Analyst — Oppenheimer

Good morning, everyone. Suraj Kahlia, Senior Medical Device Analyst at Oppenheimer. Pleased to have with us this morning, management from Pulse Biosciences CEO, Paul Aviolet, who I've known for more than a decade, and CFO, John Skinner. Gentlemen, always a pleasure to connect with you. Thank you for taking the time this morning.

Paul LaViolette, CEO

Thanks, Suraj. Great to be here. Thank you, Suraj. Happy to be here.

Suraj Kalia, Analyst — Oppenheimer

So, Paul, first and foremost, let me start out with the very obvious. Congratulations on the first demand or the EFS study for the NS360 catheter presented at AF Symposium. I mean, I think so it's fair to say it surpassed everyone's expectations. And even Dr. Reddy, you know, at the symposium said so. Obviously, there's been a lot of buzz around that. And Dr. Reddy did mention something about, you know, this is quite good, even compared to FeraPulse or any of the other modalities, but he was not able to pinpoint what was really driving the incremental efficacy. Paul, maybe to the extent, and I know it's just been a month, but what are you hearing chatter in the clinical community of why that incremental improvement in efficacy

Paul LaViolette, CEO

is being seen with your waveform? Thanks, Siraj. Yeah, so first of all, we were very pleased by our data presentation. The outcomes are, I think, unprecedented. And just to be clear, At six months, we had 100% outcomes efficacy or rhythm control. At 12 months, 96% rhythm control. And also at 12 months, freedom from all atrial arrhythmias of 90%, including event monitoring and intermediate monitoring, not just the endpoint. So the levels of rhythm control are unprecedented in their success. So then the question is why? And I think that we're in a very favorable position that folks are asking, how could these data be so positive? So that's kind of point number one. Point number two, I think we have to go back to two fundamentals. One, we deliver nanosecond PFA. Yes, it is pulse field ablation. We deliver pulse electric fields, but we are delivering really a different form of energy than all other PFAs, and I'll spend a minute on that. I think the second is that because of that different form of energy, our catheter design allows us to really deliver a one-shot solution. We have so much efficiency in our energy delivery, we can cover a larger footprint. And if you really break down the delivery mechanisms of other PFA systems, they are still delivering points of ablation. They deliver four or five points of ablation. Then you have to rotate and rotate again and rotate again. So it is still connecting dots in the pulmonary vein. And I think part of the long-term failure against that primary endpoint is that spaces, gaps exist between those spots, and those ultimately lead to reconnection. So to ask the basic question, how can PULSE be so much better? First, look at the lesion quality. Look at that singular contiguous laying down of a footprint of ablation, all done in five seconds, and all of that is derived from the novel energy. We are not a waveform difference, right? We are an entirely different type of PFA, and that is leading to deeper, more consistent, higher-quality lesions, and with single-shot delivery of that energy, there's no dependence upon technique or overlapping of lesions, which, of course, produces, I'll call it, mechanical error that can ultimately lead to reconnections.

Suraj Kalia, Analyst — Oppenheimer

Well, would I be misplaced in my thinking that compared to traditional microsecond waveforms, The nanosecond waveform, we are looking at a three-dimensional approach here. One is the total energy, in terms of joules, if I heard your comments right, is being delivered more. But then, obviously, the catheter design allows for a contiguous lesion. I mean, that's, and then the nanosecond part of it just is in terms of, you know, obviously the time needed to create a contiguous lesion. Is that the right approach overall? And is the energy, are you really pushing us towards energy as the primary, at least in the early discussions that you all have had with your clinicians? It's the total amount of energy being delivered, and it's contiguous, and boom, we get such better efficacy.

Paul LaViolette, CEO

You're on the right path, but actually, we need to think about it in the opposite direction. The total amount of energy we deliver is lower than other catheter systems that use microsecond PFA. The individual pulse that we create, of course, nanosecond being billionths of a second, is shorter in duration, and we do drive more energy in that individual pulse. But the pulse lasts for such a short amount of time that the total energy delivered for a single pulse is still relatively low. And it is so efficient in the way that energy penetrates the tissue and penetrates the cells to create electroporation, which is what all PFAs attempt to do. We end up with a lesion creation capability that produces these extraordinary results while delivering, it depends on the exact comparison, probably 75 or greater percent less cumulative energy in our ablation. And so this is something that I think is going to take a little time for the field to understand. Yes, the bursts of energy in terms of pulse duration are shorter. Yes, the amplitude is higher to create a little bit more balance, if you will, in the area under the curve for our pulse. But our pulses are so efficient that we are enabled to deliver less total energy. And because we burden our catheter lower, because we lower the total energy that catheter has to deliver, it can be much more flexible. Our electrodes can be thin wires. that leads to the entire novel configuration of our catheter design and our lesion-making footprint, if you will, that is very different and unreplicable from our competitors.

Suraj Kalia, Analyst — Oppenheimer

That is a fascinating, I think, so I need to go back, and that is a fascinating point you bring up about the total energy and the flexibility of the catheter and the electrode. Interesting. Food for thought. Paul, obviously, you know, since sticking on to that topic, one of the things that Dr. Reddy also mentioned was the mapping wasn't ideally integrated in the EFS study, right, or the phase one study. What steps have you taken in the IDE study for integration with whether CARDO or Insight? How should we think about it? Or it's going to be status quo, and we could still get 90. I think so one of the questions, Paul, you and I have talked about this. Clients are asking is like, first and foremost, this result is like really off the charts. Three standard deviations from what others are showing, right? Then you have, you lay it on top of that. Well, but it wasn't integrated properly into mapping systems. So if you integrate, does it mean incrementally even better results, right? So what have you done for the IDE as you start ramping up from a map perspective?

Paul LaViolette, CEO

Yes, it's a great point and a great clinical issue because the number of lesions one has to deliver and the need to deliver multiple lesions in a single place increases, I'll call it mapping dependence. And obviously, if you go in the opposite direction with singular lesions, essentially anatomically located, you can lower your mapping requirements. However, physicians are quite dependent upon using mapping to increase their confidence of precise location. And there is no question that if you feel a little less confident in the precision of your location of lesion creation, you might end up putting an extra lesion somewhere, right, just to make sure you have belts and suspenders. So you use the right word, integration. Most mapping systems allow for non-integrated, so other brands, if you will, ablation systems to be plugged in. And so that would deliver very rudimentary registration of the catheter on the mapping system. What you really would like to achieve is higher fidelity registration, which increases the physician's confidence of precise catheter placement and therefore ablation location. So in our EFS study or our European feasibility study, we had, let's call it base case integration with multiple mapping systems and multiple mapping systems were used in that data set. And as we migrate over time, of course, many of those cases were done throughout the course of 2024 and 2025, we now have seen through live case demonstrations at the AAF symposium and at Heart Rhythm Society symposia for live cases that we have mapped at a higher degree of integration with both the Abbott Insight system and the J&J Carto system. And so the way to think about the U.S. IDE is that we expect to have that higher level of integration available. And, of course, the individual physicians will choose their mapping systems, but we do think higher integration will facilitate improved procedures. Now, how that translates to outcomes to be determined, the irony we have, of course, is that having achieved 96 percent efficacy in, let's say, rudimentary mapping structure, one can posit that our integrated mapping should be improved, but it's difficult to improve upon 96 percent. So the goal here is not to put out a stake in the ground about higher numbers, but ultimately to increase efficiency and efficacy. And if you think about efficiency for us, it might be reducing the average number of lesions per case from 16 to 14 to 12 because they're placed with higher confidence. But our lesion-making capability of that nanosecond PFA and of the epicenter catheter is so clean and so, I'd say, confidence-inspiring that when merged with outstanding mapping, we really need only two lesions per vein, eight lesions per case, maybe a few on the carinus. But you're really talking about 10 lesions per case, each lasting five seconds. And, of course, that leads to extraordinary workflow and speed advantages.

Suraj Kalia, Analyst — Oppenheimer

Paul, if you parlay all of this, give us a sense of your IDE study. What is the level of enthusiasm, the 144 or so patients, single arm trial that we are looking at? timelines, IRBs, just kind of set the stage. How should we start thinking? And if you all have already enrolled any patients, any details that you can add on

Paul LaViolette, CEO

to what is already out there? Yes. So we have not enrolled yet. We will announce when we commence enrollment. We received IDE approval late December, commenced our work with sites in early January and are progressing multiple sites through that process and toward that starting line. We mentioned in our prior announcements about a month ago that we expect to do first patient in and commence enrollment in a few months. So we're probably halfway through that timeline now. We should be looking at early in Q2 for enrollment. The IDE is 155 patients, so a single-arm study, relatively clean in terms of enrollment criteria, should mechanically enable quite high flow of patients. So you have, obviously, a very high patient population. We're dealing with paroxysmal as an indication or target here. So these patients will be entering essentially their first therapy, their first interventional therapy to treat paroxysmal AF. So that's a very rich patient population, high flow per center. And therefore, centers, if you think about any cardiovascular study, you would measure a center on enrollment of patients per site per month. And often that's less than one patient per site per month in large studies for heart failure or for left atrial appendage occlusion. This is the kind of study where we will get multiple patients per site per month. So as you open sites, as you mentioned, as they finish their IRB approvals, they finish their contracting with us, they get ready to go, we would expect to open a wave of sites in the first month. And each of those sites then, I think to think about acceleration of the study, is able to line up, let's say, three or four patients for a single day to have essentially a pulse biosciences day in the lab. And that creates a lot of efficiency for enrollment, a lot of efficiency for clinical site support. So I would expect that will happen. And we have conveyed consistently that our expectation is we'll start the study in Q2 and we'll finish the study in Q4. Our company objective, of course, is to improve upon that as much as possible. And I think you put your finger around the most important element. Investigators can really drive an awful lot. Now, sites, if you go into a major academic institution, they might have 25 protocols going on in the EP lab, not all for AFib ablation. But there's a lot of demand for those resources. It's competitive. You have to angle, if you will, through the principal investigators and the investigative team, the study coordinators, all of their readiness and prioritization of time and attention. However, all of that is made dramatically simpler when you have a technology that is of extraordinary interest. And I would put, based on my years of experience, my dozens of PMAs and pivotal studies, the metric of interest in this study and this technology is at the highest level. And so I do believe, given the ease of use of this catheter, given the pronounced clinical outcomes that have been published so far, given the need to advance PFA to the next level, and the appearance that Pulse Biosciences is delivering that next level, I'd say the investigator interest is extremely high, and that bodes very well for our enrollment objectives.

Suraj Kalia, Analyst — Oppenheimer

Yeah, Paul, this might be a dumb question, so forgive me for this. Let's say Siraj comes in, and he has paroxysmal AF, and Vivek Reddy is at Mount Sinai. How is he going to make the decision? He would want to push it properly towards Parapulse and Watchmen together, concomitant, right? Because they make a lot of money. But now he has to push Siraj to, let's say, pulse biosciences, right? Or is it just the volume of patients is so high in your selected IRBs, you really don't envision any hiccups in the cadence and the pace of selection for the trial?

Paul LaViolette, CEO

Yeah, it's a great point. And the answer is the latter. The volume of patient flow is so relatively high. And I'll call it the cleanliness of our inclusion criteria and the lack of exclusion criteria allow for many, many patients to be consented into this study. And so when you think about hundreds and hundreds of patients flowing through a major facility such as Mount Sinai, and ultimately yielding single-digit cases per week that might go into a protocol, which, by the way, would be very favorable enrollment. If you did three or four cases a week in a protocol, think about that. That's 10, 12 a month. In three months, they would max out on their allocable case quantity to enroll. So this study is not going to be subject to any significant dilemma where patients could otherwise go into, let's say, concomitant intervention, as you mentioned. If you think about the relative label, I'll call it narrowness, right, today for what patients are on label for watchmen, of course, that's the subject of the large studies. champion will read out, all for the purpose of trying to expand the patient population toward the area of patient complexity that we're likely to treat. But really, the patients currently receiving a left atrial appendage occlusion are older, more frail, more complex. And so I don't see that sort of thing as a dilemma whatsoever. I think the clinician is, of course, sitting in front of that patient saying, you do qualify for this. Now, let me ask you, if you would like to participate, do you want to consent for this study? Let me tell you about the potential benefits of this new energy. Let me tell you about the data we've seen from Europe. Let me tell you that this is a single-arm study, so there's no risk that you'll be randomized to a control treatment. And so it actually becomes a very attractive opportunity for patients to consider consenting for enrollment. And I think that's the kind of element that simplifies overall trial enrollment. When you have a very favorable value proposition to offer to patients, a lot of those patients say, you know what, thank you very much, doctor. I would like to be in this study. I'd like to see if I can be treated better with this new therapy. And it doesn't feel risky because there's a lot of data already. And there's a possibility that I could have improved results and maybe significantly lower chance of requiring a second intervention, which is common with other technologies. That's a very attractive offer, if you will, for trial participation.

Suraj Kalia, Analyst — Oppenheimer

Paul, the other key thing that is of great interest now to clients and frequently comes up in, almost always comes up in conversations, is Pulse's approach to going direct versus going hybrid with a partner versus selling the asset to a larger strategic. And obviously, I don't need to tell you which key players in the market are struggling right now from a PFA share. And I fully respect that there are some things you are not at liberty to say, but just set the stage for us, how timelines, how should we think about, let's say, exit towards the second half, what can happen? How should we think about it specifically from the strategic collaboration, whatever perspective?

Paul LaViolette, CEO

So, very important question. I think this speaks to the strategy of the company and to the space that we're talking about. The EP space is extremely attractive. That's the good news, right? A very large market, very high organic procedure growth. This is one of the, if not the most attractive medtech markets, and we're obviously privileged to be positioned with such great data and a disruptive technology. And we have seen in the last several years, PFA has come in and has been that disruptor to the established share dynamics and the established handshake between mapping and ablation systems. That handshake has been disrupted, and it does appear now that really ablation is the leading factor in choosing technologies, and mapping is secondary. We, of course, have already established that we work with multiple mapping systems. So we are a pure play, disruptive, next generation energy to treat AFib and eventually other arrhythmias. And because NSPFA is so uniquely held by Pulse Biosciences, we expect that this energy will be the leading energy for years to come. So we then look and say, OK, well, how long would it take us to build an entire organization, enter the market, overcome the lack of mapping as part of our product system? And basically, our conclusion is that's a very risky, capital intensive and burdensome investment and launch process. So we decided to determine and declare that we'll be partnering. And then you get to the dynamic that you mentioned, Suraj. Shares have been shifting. Market positions have been changing. And the stakes are very high. Market capitalizations have been changing dramatically, purely as a function of ablation catheter market share and growth. And so we think we fit really, really well. I won't comment on individual players, but we think we're an attractive alternative. And really, if I were setting a strategy for my business, if I were running a strategic, I would be thinking, how can I combine a great mapping system and the next generation energy that's likely to lead this market for the next decade? How can I combine those two and define for myself a leading and controllable market share position for five to 10 years? That is a dream come true for someone who runs a business unit, I can tell you. So how those partnerships shake out, exactly what structure they'll ultimately take, that is to be determined. We're not going to speculate on that, but I think the most important element is to start with an extremely attractive asset, which is the combination of everything we've built in the intellectual property, the novelty of NSPFA, the ability to translate that novelty into ease of use, workflow simplicity, improved outcomes. and those dynamics will lead to partnership power.

Suraj Kalia, Analyst — Oppenheimer

Would I be jumping the gun and saying it seems like you're more inclined towards a distribution arrangement, or you would say that's not necessarily true today? It could be at the

Paul LaViolette, CEO

right price, a sale is also on the table. No, I won't comment on, again, one type of agreement. Our job, of course, is to do the right thing for our shareholders and to create value long-term, and in the end, we'll do the right thing. The most important thing for us right now is to focus on execution, to focus on delivering these data points, delivering follow-up from Europe, initiating the study in the U.S., demonstrating that we are delivering on all of our commitments to the marketplace. As we do that, we become incrementally desirable and I'll call it magnetic, right, as a technology that can be disruptive in a partnership structure.

Suraj Kalia, Analyst — Oppenheimer

Well, the other thing that was news yesterday about slow burning, I just created a new word, the nano clamp on the surgical side, but the ID is still going ahead. Quickly, if you could just lay out the landscape, what made your shift gears a little bit or downshift your gear

Paul LaViolette, CEO

on the surgical AF side? So surgical AF, we're not really downshifting. What we are doing is upshifting EP. And of course, everything I just described for the last 15, 20 minutes about the quality of our data, the magnitude of the EP market, the speed with which we want to move into that market and concentrate our effort and focus our resources on what we can do to build value in that overwhelmingly attractive space in the form of trial execution, additional clinical studies that could be designed and pulled forward, acceleration of our product development pipeline. All of those things are so compelling that we have a capital allocation challenge and simply look at the clamp for preoperative AFib treatment concomitantly in surgery. And we say, okay, this remains a very attractive standalone opportunity. It has all the drivers of attractiveness that it had a year or two ago when we focused on it to begin with. We're committed to completing that IDE. So there's no change in our IDE enrollment plans, but other areas of investment in that product franchise, including next generation, let's say, product development or future feasibility studies in Europe that might tease out more value in the CLAMP specifically, those sorts of things we will not do now. And instead, we would allocate those resources over to EP so that we can really drive that program, which we feel and everybody else would acknowledge has the highest return potential for the company. Fair point.

Suraj Kalia, Analyst — Oppenheimer

John, in the couple of minutes that we have remaining, if I could, obviously there's been a shift from the surgical program. Like Paul said, you all are upshifting on the endocardial side. Set the stage for us in terms of your cash needs, your cash allocation, your cash burn, you know, through the year. How should we think about it? I think so you guys filed a $200 million registration shelf recently or maybe a $60 million ATM. Just kind of set the stage for us, all the moving parts, if you could.

Jon Skinner, CFO

Sure. Yeah, absolutely, Siraj. So we had $80 million in cash at the end of 2025. And as you mentioned, we had a $60 million ATM that is in place as well as a $200 million shelf registration that we put in place. So those are two vehicles we have to opportunistically bolster the balance sheet and continue delivering on the key clinical programs that Paul mentioned. And then coupled with that, we also have the partnership structure, which could be another vehicle for us to bring capital into the company. Obviously, we don't know exactly the timing or the structure of those yet, but those are the three different avenues we have at our disposal to bring cash into the business. But where we are situated today is we have enough cash to run and hit these high clinical milestones that we have during 2026 on the two IDEs. And as Paul mentioned, we're going to continue to allocate more resources towards the EP program. So that continues some reductions on spend with regard to the surgical clamp and also some reductions in selling and marketing spend related to the thyroid business. But overall, on a gross pulse basis, we're not doing this reallocation to spend less money overall. It's a reallocation to deliver more capital towards the EP business, which is the highest value program we have. We want to generate the highest returns and most value for our business moving forward.

Suraj Kalia, Analyst — Oppenheimer

And, John, quickly, the current estimates for OPEX in consensus, that's roughly appropriate. Now, the components might change, but you would say for FY26, the OPEX estimates out there are roughly okay, or should we be jacking those up?

Jon Skinner, CFO

Yes, I'm not going to comment specifically on the consensus numbers that are out there, but we did have a $15 million cash burn that we had in Q4, and we do expect those to increase throughout the course of 2026, and that's largely tied to the two IDEs, so we're spending more money on the R&D side of the business throughout the course of 2026 and has those IDEs enroll. We have a clamp one that's been up and rolling over the past couple months, and the EP catheter will have first patient here in the near term and then enroll throughout the course of 26, So, towards that middle point of the year, when both of those studies are up at their highest velocity, it should be when the burn does take up the most, and so we do expect to spend more capital throughout the course of 26 versus what we did in 2025.

Suraj Kalia, Analyst — Oppenheimer

Perfect. Gentlemen, we are up on time. Always a pleasure. Congrats on all the progress. I'm sure there'll be a lot of news flow towards the summer, and we look forward to continued conversation. Thank you so much for your time.

Paul LaViolette, CEO

Thank you, Siraj.

Suraj Kalia, Analyst — Oppenheimer

Thanks a lot, Siraj.

Paul LaViolette, CEO

Take care.