Conference Transcript - PLSE 2026-08-11

Bill Plovonik, Analyst — Canaccord Genuity

All right. Good afternoon. Welcome to the Canaccord Genuity 46th Annual Global Growth Conference. My name is Bill Plovonik. I'm a Senior Medical Device Analyst here with Canaccord. With us up next, we have industry legend, Paul LaViolette, President, CEO, and Co-Chair, Pulse Biosciences, and then John Skinner, CFO, is in the audience. He may be yelling a couple answers here and there. We are just going to have a fireside chat. Paul ensured me that he'll be able to explain the technology without a slide, or maybe he'll throw a slide up there. So thanks for coming and joining us with us.

Paul LaViolette, CEO

Thank you, Bill. Great to be here.

Bill Plovonik, Analyst — Canaccord Genuity

So we have only covered Pulse for, I think, like three months of stocks, I think 70%, 80%. It's moved a lot. Let's just put it that way. But also, I mean, you and I have known each other for a while and you joined this company two years ago.

Paul LaViolette, CEO

Yes. Yeah.

Bill Plovonik, Analyst — Canaccord Genuity

First on the board and then quickly into the CEO role. And I'd say the company has made a lot of progress in a very short amount of time under your after you took over. And you also have a very differentiated technology in what's, I would say, probably a white-hot space in MedTech. So this is going to be fun. Before we really dig into this, I want to take a step back and focus on management and the board's experience because I think it helps really frame this for investors. investors. Let's talk about your corporate and your VC experience and how you got it. How'd you even get into MedTech? And I know we're going back a little, but I think it's going to be helpful for investors.

Paul LaViolette, CEO

Sure. So I got into MedTech in 1980. I was a summer intern for Kendall, which became part of Medtronic. And they hired me before I even went back to my second year of business school. So I was 23 and working in marketing and medtech. I stayed there for four years and then made an important move for me, which was to go to CR BARD. BARD at that time was launching the first interventional cardiology platform in the world with the first coronary angioplasty system. And so I became part of that, ultimately ran that business, stayed at BARD for nine years, became president of cardiology across foretelling the electrophysiology, peripheral vascular, and coronary vascular space. I then joined a company at that time I had never heard of in Boston called Boston Scientific. And it was a $200 million company at the time. I joined as the president of International, went on to run groups of divisions across the med-surg group, the endosurgery business, if you will, president of cardiology, group president of cardiovascular, chief operating officer over all business units, all operations, and that spanned 15 years and moved the company up to $8 billion. That was then 30 years in aggregate experience, and I retired at that point, 2008, became a venture capitalist, started to invest in medtech companies, and joined some boards, both public and private, as an independent director. Spent the last 18 years doing that and sold a lot of companies, made a lot of investments, and have some lasting boards, including companies like Edwards Life Sciences. And I was contacted by Pulse in 2024, looking to add an experienced MedTech veteran, if you will, to the board. And really just in an interaction with Bob Duggan, one thing led to another. He asked me to join the board. I did. And almost immediately flipped into the CEO role. So it's been a fantastic process. I will say I did diligence as a VC would in Pulse and started to look at the technology, look at the markets, And I just, we can talk more about it, but I found in it something that I thought was absolutely exceptional. And so I tell folks that the board asked me to join as CEO in a car, leaving the parking lot on the way to dinner. And I said yes on the spot. And then I told my wife after that. So don't take marital advice from me. But I was so convinced about the technology that I didn't need to think twice about the opportunity.

Bill Plovonik, Analyst — Canaccord Genuity

Yeah, and I want to go over that. I think it's so important you've worked at, you've built companies, you've worked at large companies making acquisitions, you've invested in small companies. It's kind of you've seen the good, the bad, the ugly, the non-linearity of it and how to build and how to dismantle. So it's kind of you've been there through the whole process. I think that's important as you build a company. I also want to kind of you mentioned Bob Duggins. Yeah. For those that have met him, he is definitely a force in nature. But I think, you know, his track record is impressive.

Paul LaViolette, CEO

Well, Bob is an impressive human and his track record in business is matched, frankly, by his track record and in other non-business activities. He's a remarkable person. I met Bob in this process. I did not know of Bob. I knew of his work. I knew of his building of computer motion and the merging of computer motion with Intuitive Surgical. He was then on the board of Intuitive for a decade after that.

Bill Plovonik, Analyst — Canaccord Genuity

A 30% shareholder of intuitive.

Paul LaViolette, CEO

A 30% shareholder of intuitive and a forerunner, really, in the entire development of the robotics space. I think that's an example of Bob's vision. And importantly, what he's done subsequent to that is even larger, right? So if you think about putting it in context, most executives would take that one accomplishment and call it a life. But Bob, of course, developed and sold Pharmacyclics. He's done it again with Summit Therapeutics. He is, he's older than I am, enough so to call me young Paul, which I really, really appreciate. And I will say Bob brings spirit, but also he's deeply analytical. He's super smart. He's got financial instincts like no one else. And I think the way I think about it, it's a privilege to work with Bob. And if I'm an investor in Pulse, I think, okay, I can invest in great technology and a strong team, but I get sort of Bob comes along with the package, which is a real added benefit.

Bill Plovonik, Analyst — Canaccord Genuity

And, yeah, for those that aren't familiar, I mean, I think Bob owns about 70% of the company.

Paul LaViolette, CEO

That's right. And importantly. He has continued to invest. He has invested as a public equity shareholder, right? He didn't come in with some kind of pipe conversion or something. He buys shares. He has invested capital. He has used that capital to build this company and preserved his ownership because of his belief in nanosecond PFA.

Bill Plovonik, Analyst — Canaccord Genuity

And any other key executives that you'd like to highlight or point out that we should, as investors, be aware of?

Paul LaViolette, CEO

Well, I like to tell everyone in the company that they all have jobs that are more important than mine. So I can't list them all, but if you think about our technology team, the technology is really unique. Actually, several of the members from Computer Motion and with this longstanding relationship themselves and with Bob have driven the development of this unique form of energy. And that would be Darren Uecker, Dave Danitz as the CTO and the senior vice president of R&D. And then on the clinical side, given that we're a clinical stage company and principally being monitored now for the effectiveness of our enrollment in the IDE for EP, it really comes down to David Kenningsberg is our chief medical officer. Leanne Toplitsky is our COO. That group really drives the day-to-day activities. But we have a very strong team, and I think it's executing well.

Bill Plovonik, Analyst — Canaccord Genuity

So let's talk about the technology. What makes it different? What is it?

Paul LaViolette, CEO

Well, ablation is performed across the body, across the globe, millions and millions of times, and it's an enabling technology to reduce interventional burden on the body and treat tissues less invasively. So that is the unlock in millions and millions of therapeutic interventions. Ablation has evolved from hot and cold, right, burned tissue with radiofrequency, to now this newer field of pulsed electric fields, pulsed field ablation, using electricity to non-thermally ablate cells and cause irreversible electroporation. So the whole concept of electroporation is now relatively well established, and it is taking markets by storm, and the first market example of that, of course, is atrial fibrillation, the largest and one of the whitest hot spaces, as you alluded to earlier, Bill. Nanosecond PFA is the technology that we have developed, we're the source of, and we control with that great team that I described and 250 patents and years of development experience and know-how. And I'll suffice it to say we can talk more about it in detail, but it is a next generation. It is really a new form of energy. It produces unique biological after effects, particularly regulated cell death. It actually causes cells to trigger their own demise and eliminates tissue without causing an inflammatory response in the body. It's really, really remarkable. And because it is non-thermal, it can be used in tight spaces and adjacent to sensitive structures without causing any damage. And that produces tremendous potential. the first and most important manifestation of is obviously AFib.

Bill Plovonik, Analyst — Canaccord Genuity

You've invested in a lot of companies in your career and been part of companies. I always like to say your time is the most valuable asset you have, and you voted with your feet and joined. If I put your VC hat on and say, okay, these are the top three boxes, This checked, which made me jump at the opportunity to be the CEO and run this. What made you decide to provide your time to this company?

Paul LaViolette, CEO

Well, in the super broadest terms, it's team, it's technology, it's things like that. But a little bit more granular than that, as I mentioned, ablation is a form of therapy that can treat basically everyone in this room. Everyone we know will be ablated for some problem on their body at some point. And so we've seen over time ablation emerge, again, as I mentioned, in millions of procedures per year. And ablation evolves in waves, and it generally is enabled by better energies over time. And each one of those energies takes over the prior wave and then is proliferated across diseases and becomes more and more competitive as multiple companies introduce like products. And that's happened with microwave and high-intensity focus ultrasound and with radiofrequency, obviously. And that's happening now with PFA. And PFA is taking over all other forms of ablation. At no point along all of those evolutionary cycles in ablation has there ever been a time when the next energy was far superior to all prior energies and where only one company could practice it. That's an answer.

Bill Plovonik, Analyst — Canaccord Genuity

All right, let's get into the trial then. So you have a catheter ablation trial, which is your first, I would say, big indication you're really going after. and that's with the Nanopulse AF trial, has to be one of the fastest enrolling trials in cardiac ablation ever. What do you think has been the key driver for this enrollment? Why is it so fast?

Paul LaViolette, CEO

Well, physicians are excited about the technology, and I think physicians are excited about the technology for two main reasons. One is we've done a very large European feasibility study that now numbers over 175 patients. Many of those patients followed out over a year. And that study, using the same endpoints that we'll use in the IDE, has produced clinical efficacy levels in AFib, the world's number one arrhythmia, of completely unrivaled levels. And so if you think about AFib success today, all of us could be subject to atrial fibrillation and we go into our physician they say okay fail some antiarrhythmic drugs you've got paroxysmal af we want to treat you the best technology today will deliver a 75 probability of success which is to say realistically four of us get treated one of us will need a repeat intervention that's not all that bad but in modern medicine, you ought to be able to do better. And our data reduced that 25% failure rate to 4%, which is a leap of efficacy that is unprecedented. Now, it has to be replicated in the IDE. The second element is that under this crush of AFib, physicians are trying to do more and more procedures and it's a complex procedure done with rf on a point-to-point ablation basis doing pulmonary vein isolation might take 100 ablations 125 and an hour and 15 hour and a half the next generation first gen pfa reduce that to 45 to 50 minutes and maybe 40 to 50 ablations we reduce 50 ablations to 10, and we reduce the operative time where that physician is moving the catheter from the first ablation to the last to maybe seven to eight minutes on average. So if you think about throughput in the lab, you think about physical burden and intellectual burden on the electrophysiologist. You think about how many literal mechanical manipulations of the catheter in order to affect a result, and all of that, reducing all of those variables that allow for an ultra-fast procedure, more patient throughput, much more economic efficiency, the ability to treat more patients and reduce the backlog, and while doing all of that, potentially increase the therapeutic effect from 75 percent to 90 plus percent. That's what we have the potential to look forward to.

Bill Plovonik, Analyst — Canaccord Genuity

And I think to go back to point one, you already have the European data. So like a good lawyer would say, I'm asking a question I know the answer to. So you're running the U.S. Pivotal knowing likely what the answer is.

Paul LaViolette, CEO

Well, knowing the range of the answers, right? And there are, of course, you move from all those folks on their Mediterranean diets in Europe to the United States. We have maybe incumbent higher risk factors, slightly sicker patient population. But your point is well made. The transferability of the data, and we worked hard on this. We have some of the same operators. We have the same endpoints. We have the same protocol. And if you then say, well, what are the factors that could potentially lead to a different result We're trying to minimize those as absolutely much as possible because the catheter is applied using the same technique as all physicians are used to or have become used to with Boston Scientific Verapulse. We're not asking really physicians to adopt a new learning curve. There's no real technical advance here. And ultimately, we're reducing the burden on the physician by saying, you know, that Boston scientific approach you currently use today successfully, but you deliver 40 to 50 ablations, do that exact same thing, but only deliver 10, which you can just imagine reduces interoperator variability and reduces the chances for any one thing to go wrong. And so it should deliver well. And then the last thing is that we have integrated it with advanced mapping. So the representation of the catheter in these procedures will be very similar to what they're used to and was not available to that degree in the feasibility study. So actually, we're driving the car today with high beams on, and that was not the case in the EU study.

Bill Plovonik, Analyst — Canaccord Genuity

Why shouldn't we be worried about you adding patients to a study? Historically, if somebody adds patients to a study, that's a bad sign, not a good sign.

Paul LaViolette, CEO

Well, the reason is because we have a really good answer as to why we added a few patients to the study. So, yes, it's common maybe for studies to be expanded because folks are worried about futility and adding patients to add power. That wasn't the case here at all. We were, patients that undergo ablation for AFib have to fail antiarrhythmic drug therapy first. They have to show that they're non-responsive to AADs, and then they can qualify for ablation. In today's market, because PFA has become so attractive, patients want to have the most expeditious route to ablation as they can get. And that's what they're getting in the real world. So when you enter patients into a protocol, you want to have that replicate the real-world experience as much as possible. And this practice is changing quickly. Our initial protocol called for a rather rigorous failure rate or failure mode for antiarrhythmic drugs. And after we got into the protocol, the physicians in our study basically said, you know, this is a pain in the neck. Our patients don't want to undergo this. And there's no evidence that shows there's any difference in how patients perform, whether they failed one type of antiarrhythmic or another. So they came to us and said, would you please go to FDA and change this? And in the process, we did so. FDA agreed, and we added less than 20 patients to the study, which is something that we found so immaterial. It didn't matter. And our enrollment velocity is so relatively quick, as you alluded to earlier, that the extra time to enroll the extra handful of patients is so small that it became a sleeves off our vest decision.

Bill Plovonik, Analyst — Canaccord Genuity

So I think it's interesting, you know, you as a VC, you were even invested in this space in a company in the cardiac ablation. So you've seen the good, the bad, what worked, what didn't work, but you probably understand the competitive landscape better than anyone given that is I'm sure you're looking at it. So as you look at the competitive products out there today, and you may not answer this question, but who do you think has the most competitive, the least competitive? Because that helps inform us of who would be most interested in partnering with you.

Paul LaViolette, CEO

Well, most competitive and least competitive, I think it's very easy to measure that just based on market share trends. And so I don't have to indict anybody. Boston Scientific obviously took the market by storm with FARA Wave over the last couple They did, without a doubt, they did an absolutely stellar job launching that technology and converting the market to PFA. Of course, upon the launch of Sphere 9 from Medtronic, predicated on the Afera technology platform, Boston has seen share erosion and Medtronic has seen share gain. I think a couple of things are important there. One, the switching speed between PFA platforms is demonstrated to be very quick now serially. Number two is that in the absence of new technology launches such as those, the other players are absolutely stagnant and generally eroding and growing slower than the market. The market has wholly, not completely today, but has predominantly shifted to PFA and is expected to have wholly converted to PFA over the next year or so. So I think what it demonstrates to us is that there is a voracious appetite in the market for the better ablation technology. We are demonstrating that we have that. Unlike the current swapping of share between microsecond PFA competitors, there will be no other NSPFA competitors. And I also think what's been demonstrated is that the dominance in the market in the last 10 years, which was driven by mapping superiority and mapping footprint domination, that has given way to ablation leadership. And so that bodes well for Pulse Biosciences.

Bill Plovonik, Analyst — Canaccord Genuity

We have about a minute and a half left. I'd love to open this up to see if there's any questions from the audience. Must be getting all their questions answered. AFib is the first indication you're going for?

Paul LaViolette, CEO

So the question is, is AFib the first indication we're going for? So AFib is a, to get an AFib label is a class three device. And so we're doing a PMA to get approval and an on-label claim for AFib. We already have a clearance of this technology in a non-cardiac use under a general soft tissue ablation clearance, and our first use example there is to treat benign thyroid nodules. That's an extremely attractive opportunity for a number of reasons we can talk about, but currently patients undergo complete removal of the thyroid to address benign growths. We think that's really unfortunate and ideally avoidable, and so that's an example of where NSPFA can really change the lives of patients and convert a market from open surgical excision to less invasive delivery of this elegant energy, and I think that's a perfect example of what NSPFA can do across multiple applications going forward. that's the last question if i could you know you've talked about partnership strategy in the cardiac ablation market in the past um but consider you know and this was developed a couple of years ago as you were coming in and doing all this and now that you've watched the

Bill Plovonik, Analyst — Canaccord Genuity

market develop you see that the ablation matters and you can shift share based on that why wouldn't you build your own channel and go after the market especially if you have no competition coming Right.

Paul LaViolette, CEO

So it is still a it's an area under the curve exercise. How quickly can you get in? What's the cost to do that? What's the risk of execution against the scale of that market, the entrenchment of competition? And I would say the interwoven product utilization between mapping, ablation and all the attendant accessories associated with that. It's a very complicated market. And so I do think, to your point, it is absolutely feasible that we could do that. But I think we as a board and our management team believes that the greatest way to create the most value in the shortest amount of time and to bring this enabling technology to physicians and patients is through a partnership.

Bill Plovonik, Analyst — Canaccord Genuity

I think we're going to have to end it there. Thank you so much. Thanks, Bill. Great time.