Yeah. All right. Good afternoon. Welcome to the Canaccord Genuity 46th Annual Global Growth Conference. My name's Bill Plovanic. 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 of Pulse Biosciences. Jon 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. Thank you, Bill. Thank you. Great to be here. We have only covered Pulse for I think three months. The stock's, I think, 40% or 70%, 80%. It's moved a lot, let's just put it that way. You and I have known each other for a while, and you joined this company two years ago? Yes. Yeah. First on the board, 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 after you took over. You also have a very differentiated technology in what's, I would say, probably a white hot space in med tech, 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. Let's talk about your corporate and your VC experience and how'd you even get into med tech and Yeah. I know we're going back a little but I think it's going to be helpful for investors. Sure. So I got into med tech 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 in med tech. I stayed there for four years and then made an important move for me, which was to go to C. R. Bard. Bard, at that time, was launching the first interventional cardiology platform in the world with the first coronary angioplasty system. 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. 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 surge 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 med tech 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 Lifesciences. I was contacted by Pulse in 2024, looking to add an experienced med tech veteran, if you will, to the board. 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 we can talk more about it, but I found in it something that I thought was absolutely exceptional. 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. I said "Yes" on the spot. 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. Yeah. I want to go over that. I think it's so important. 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 nonlinearity of it, and how to build and how to dismantle. So it's kind of you've been there through the whole process, and I think that's important as you build a company. I also want to kind of hit, you mentioned Robert Duggan. Yeah. For those that have met him, he is definitely a force of nature. Yes. His track record is impressive. Bob is an impressive human, and his track record in business is matched, frankly, by his track record in other non-business activities. He is 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. A 30% shareholder of Intuitive. 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. 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's older than I am, enough so to call me young Paul, which I really, really appreciate. 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. The way I think about 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 Bob comes along with the package, which is a real added benefit. For those that aren't familiar, I think Bob owns about 70% of the company. That's right. That's right. Importantly, He has continued to invest. He has invested as a public equity shareholder. 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 Pulsed Field Ablation. Any other key executives that you'd like to highlight or point out that we should, as investors, be aware of? 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, with this long-standing relationship themselves and with Bob, have driven the development of this unique form of energy, and that would be Darrin Uecker, David Danitz as the CTO and the Senior Vice President of R&D. 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 Kenigsberg as our Chief Medical Officer, Liane Teplitsky as 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. Excellent. Let's talk about the technology. What makes it different? What is it? Well, ablation is performed across the body, across the globe, millions and millions of times, and it is an enabling technology to reduce interventional burden on the body and treat tissues less invasively. That is the unlock in millions and millions of therapeutic interventions. Ablation has evolved from hot and cold. Burn 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. The whole concept of electroporation is now relatively well established, and it is taking markets by storm. 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 are the source of, and we control with that great team that I described, and 250 patents, and years of development experience and knowhow. 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 is really, really remarkable. 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. You have 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? 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. We've seen over time ablation emerge, again, as I mentioned, in millions of procedures per year. Ablation evolves in waves. It generally is enabled by better energies over time. 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. That's happened with microwave and high-intensity focused ultrasound and with radiofrequency, obviously. 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. All right. Let's get into the trial then. 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 Nano-Pulse 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? 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. 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. 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 anti-arrhythmic 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. 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 reduced 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. 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% to 90-plus percent. That's what we have the potential to look forward to. 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. You're running the U.S. pivotal knowing likely what the answer is. Well, knowing the range of the answers, right? 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. 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. 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. 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. It should deliver well. 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. Actually, we're driving the car today with high beams on, and that was not the case in the EU study. 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. Well, the reason is because we have a really good answer as to why we added a few patients to the study. 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. Patients that undergo ablation for AFib have to fail anti-arrhythmic 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 anti-arrhythmic drugs. After we got into the protocol, the physicians in our study basically said, "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 anti-arrhythmic or another." So they came to us and said, "Would you please go to FDA and change this?" 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. 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. I think it's interesting. You, as a VC, you were even invested in this space in a company in the cardiac ablation. 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, as I'm sure you're looking at it. 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. Well, most competitive and least competitive, I think it's very easy to measure that just based on market share trends. I don't have to indict anybody. Boston Scientific obviously took the market by storm with FARAWAVE over the last couple of years. 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 Affera 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. 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. 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. That bodes well for Pulse Biosciences. 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. Is AFib the first indication you are going for? The question is AFib the first indication we are going for? To get an AFib label is a Class III device, so we are 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 is 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 is really unfortunate and ideally avoidable. That is 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. I think that is a perfect example of what nsPFA can do across multiple applications going forward. The last question, if I could. You have talked about partnership strategy in the cardiac ablation market in the past. This was developed a couple of years ago as you were coming in and doing all this. Now that you have watched the market develop, you see that the ablation matters, and you can shift share based on that. Why would not you build your own channel and go after the market, especially if you have no competition coming? Right. It is still an area under the curve exercise. How quickly can you get in? What is the cost to do that? What is 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 is a very complicated market. 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. I think we're going to have to end it there. Thank you so much. Thanks, Bill. Great talking.