I'm one of the Senior Med Tech Analysts here at Canaccord Genuity. Thank you all for joining us for our 44th Annual Global Growth Conference. I have the pleasure today to introduce Pulse Biosciences, and with me today is CEO Burke Barrett. Thanks, Burke.
Thank you, John. Good morning, everyone. I wanna thank the Canaccord team for the invitation to Pulse to participate in the conference. It's great to be back here again this year. Here are our forward-looking statements. Pulse Biosciences is an ablation company, and we are developing what we believe is a next generation of nanosecond pulsed field ablation. It's both a proprietary and a differentiated and unique approach to ablation, and we truly have a mission to help as many people as possible with nano PFA. Ablation is ubiquitous. We, every day across the world, thousands of times a day, kill bad cells with heat of all types: cautery, radiofrequency, laser, microwave, with cold, with radiation, and even now with micro PFA.
There are, however, shortcomings to the current ablation approaches, and they primarily have to do with being able to control the cells you kill, to be able to kill the targeted cells without damaging surrounding tissue and surrounding cells. Pulsed field ablation represents a true ablation breakthrough, and as I'm sure many of you know, has had rapid adoption in the field of electrophysiology, in particular for the treatment of atrial fibrillation. But it's not without its shortcomings. Outcomes are variable and dependent on user's experience and skill, as well as the specific catheter design. Also, once commercialized, the speed and perceived safety of micro PFA can lead to over-ablation. Most standard PFA devices coming to the market now use RF-style designed catheters to deliver micro PFA, and were not specifically designed for PFA.
Pulse Biosciences' nanosecond PFA is different at the physics and the engineering level, and I will show you in a moment, has the potential to deliver different user experiences and clinical results. If you see on the left panel, this is a waveform, a pulse, if you will, of micro PFA. See, the pulse is not high, that's the amplitude. You see it's wide, that's the pulse width, and you compare that to the panel in the middle, nano PFA. Short durations on the order of two orders of magnitude shorter, about a millionth of a second in pulse width, but with a higher amplitude, and here amplitude represents voltage. Because we can deliver nano PFA, we can deliver a controlled energy delivery space or volume, a controlled ablation footprint. We can deliver deep ablations and typically, comparatively to micro PFA, deeper than micro PFA.
We can design catheters, and I'll show you one in a moment, where the electrodes are larger than can be delivered with micro PFA. And this leads to faster ablations, and we believe will ultimately lead to better user experiences and better patient outcomes. Pulse Biosciences is a pioneering, original company in the space of PFA. The company was founded a decade ago, but the scientific basis of the company extends back another decade. So a total of 20 years of scientific experience, started in the research lab of Dr. Nuccitelli, who was a Co-Founder of the company, and still comes into the office every day in Hayward. The scientific foundation of the company has led to an extensive intellectual property portfolio. We have over 150 issued global patents.
In developing nano PFA, in developing the generator, the console to deliver nano PFA had its challenges, and each one of those challenges, once overcome, represented an opportunity for invention, which the company fully exploited. It's a broad and deep intellectual property portfolio. It also means that we understand the science of delivering nano PFA. We have the world's largest preclinical library of pictures, gross histology, microhistology, pictures of the effects of varying different parameters of the nano PFA waveform on different types of tissue. Here are just a few examples. We have thousands of these, and what I believe this will translate to is the ability to develop products and take them into the clinic in a streamlined, rapid manner. We have an outstanding team at Pulse. In addition to myself, we have Kevin Danahy, who happens to be here with us today, our Chief Commercial Officer. He's also a former CEO.
Darrin Uecker, our CTO, was also a former CEO. We have a strong team on the clinical side. We have two renowned cardiothoracic surgeons who are part of the team, part-time now. Gan Dunnington is our Chief Medical Officer, Niv Ad is our Chief Science Officer, an outstanding Board of Directors, including the addition just this week of Paul LaViolette as the Co-Chair of the Board. Excited to have Paul with us here this morning. So a little bit more now on what Pulse has done and what Pulse will be doing, taking nano PFA into the clinic. Pulse started with a dermatological application, straightforward, treating various lesions on the skin, and demonstrated the product's clinical usefulness, treating over 6,000 patients with a great safety record. It also demonstrated that the team could scale commercially. Moving forward, we're focused on three other specific products or product lines.
The first is in soft tissue ablation, and our customers right now are focusing on the treatment of benign thyroid nodules, and then two cardiac applications: a surgical application for atrial fibrillation, as well as an endocardial catheter-based application, also focusing on atrial fibrillation. One of the strong elements of Pulse that occurred in the development of the product was to create the generator, the nano field ablation console, so that it could be used in all of these different clinical applications. So you see in the middle of the screen here, this console. In the very middle of the console, there's a small connector, and each of the different surgical hand pieces, catheters, or disposables have a smart chip in them, and they connect to the same console.
Once they connect to the console, the GUI, the user interface for that application comes up, and all of the appropriate dosing comes up. With a single console, you can perform any of the procedures that I'm gonna be speaking about today. The approach that Pulse Biosciences is taking to develop its products is to focus on high-quality clinical data. We believe in the performance and the potential performance of the devices, and that we believe that backed by high-quality clinical data and specific indications, that once approved, we will achieve the most rapid market adoption possible. I'll describe in a moment for each of the three applications the plan, but in general, we're going to validate clinical performance with high-quality clinical studies and then move quickly with specific indications into the market.
Here's a quick overview of where we are with the three products. The soft tissue ablation product, as I said, is focused right now on the treatment of benign thyroid nodules. We've completed first- in- human studies in Italy and recently first human experiences in the U.S. based on a 510(k) clearance for soft tissue ablation, a so-called general claim. We are gathering clinical experience from Italy as well as from these initial clinical sites. We plan to sponsor investigator-sponsored studies in the U.S. to inform us on the clinical performance of the device and to help us design a pivotal clinical study, which we plan to approach the FDA with. And we believe in the first half of next year, we'll initiate a pivotal clinical study for the treatment of benign thyroid nodules.
The timing of completion of the study, the regulatory submissions and approvals are not known yet. We have to first discuss the study design and get alignment with the FDA. The second application, the epicardial ablation application, you see here in the picture, what looks like a cardiac clamp. We have just initiated our first in-human study in the Netherlands. The preclinical data for the application are very compelling, and I'll show that in a minute. We received breakthrough device designation from the FDA, and more recently, FDA enrolled us in their so-called TAP program, which is an element inside of breakthrough devices. Not every breakthrough device becomes a TAP device.
We believe that combined breakthrough device and TAP will allow us to have expedited discussions with the FDA and should allow the FDA to work with Pulse Biosciences to come up with novel clinical study designs to support a pivotal clinical study, and our plan is to seek a PMA approval so that we get a specific indication for this device for the treatment of atrial fibrillation. Last, our endocardial, you see our picture down there, it's a 360 catheter. It's a PVI ablation tool, primarily. We completed our first 30 patients in Prague. We've expanded the study. We're already treating in the second half of that cohort. The study is now approved for up to 60 patients.
We will be adding at least two other centers in Europe to gather feasibility study, and informed by this clinical experience, we will be approaching the FDA with a pivotal clinical study design. This device will ultimately come to market once, once there's a successful completion of the pivotal clinical study design via the PMA pathway. So just a little bit more on soft tissue ablation. It's a significant market. Typically, what you see is this sort of swollen area in the neck, this benign nodule, and the two main choices for patients are either to have it surgically resected, so cut out, and there, of course, there's the considerations of cosmesis. You have a scar. You might also have to go on lifetime hormone replacement therapy, or the other primary option for patients is to just wait, to wear a scarf.
But eventually, as the nodule gets larger and larger, it puts pressure on all of the surrounding structures, and it causes discomfort. There are RF needles that are used in this area, but because the thyroid is so near to important structures like the trachea, the vocal cords, cranial nerves, the jugular, the carotid, the vagus nerve bilaterally, they have not penetrated the market in a significant way. We believe that with nano PFA, the ability to shrink the size of the nodule without damaging thermally the surrounding structures, creates a huge market opportunity for Pulse Biosciences. Here's an example of a patient that was treated recently in Italy.
It might be a little hard to see on the screen, but you can see the before, the left side of the neck, the thyroid is swollen, and just 30 days later, you can't see the nodule, you can't see any scarring from the small needle entry point. This is a very, very fast symptom reduction compared to what is typically seen, for example, when radiofrequency or microwave ablation is used for the treatment of benign thyroid nodules. So we're very excited about the potential of the device here. We will also be looking at other clinical indications and applications for this needle, and consistent with what I said earlier about our approach, we'll take each application, we'll understand it, we'll design an appropriate clinical study, and we'll seek specific indications. So a little bit more about our epicardial surgical ablation tool.
The market is significant in size. I'm not going to spend a lot of time talking about the market. I'm sure most of you here are familiar with this market. Here's the tool. The initial tool we have is a bipolar clamp. Basically, you put the cardiac tissue between the clamp. It might be the pulmonary veins, it might be part of the left atrium, and you make a line. It's part of the Cox-Maze procedure. What's different and what's really exciting about the way nano PFA works in this particular clinical application is that the lesions are delivered through thick tissue, always transmurally, crisp, demarcated lesions in less than two seconds. And everything I'm telling you right now is based on extensive preclinical studies, and that compares very favorably to the standard of care, which is to employ a similar approach using radiofrequency ablation.
As I mentioned, we've just initiated our first-in-human study in the EU. It's designed for up to 30 patients, and as far as I know, a unique element of our study design is that all of the patients, about three months post-treatment, will undergo an endocardial or catheter-based mapping to confirm the durability, chronically, of the lesion set. We will be presenting soon to the FDA an outline of our pivotal clinical study design, and we intend to initiate our pivotal clinical study in the U.S. in the first half of next year. Now, on to our endocardial ablation product. This is the space that I spent 20 years in, and I'm quite familiar with the market, the clinical studies, and the path through the regulatory process.
I think everybody here knows this is an enormous market that year after year continues to grow double digits. On the left of this panel, you see our 360 catheter, and here I want to come back, and I want to point out some elements of the design of the catheter that are uniquely possible with nano PFA. If you look at the catheter, basically, you see two circles, an inner circle and an outer circle. Each of those circles is a single electrode, a single electrode. If you're familiar with micro PFA devices, any of the many of them that are available, and you think about the design of them, they all have two or more, more or less small, circular electrodes, and you ablate across pairs or many pairs quickly, but across many pairs of the electrodes.
That is, in essence, a design limitation of micro PFA. Micro PFA operates at current levels where you can't build big electrodes like you see on this catheter. They'd get hot, and in extreme use, they would melt. So what we're able to do, because we're operating at very low currents with nano PFA, is essentially have a true one-shot or single-shot PFA device. So energy. It's a bipolar device, and energy is delivered between those two circles, all a single pulmonary vein. A single energy delivery can be delivered in less than 5 seconds, and you can see how well demarcated the lesion is in the gross pathology picture on this slide. This has the potential to really be transformative in the delivery of PFA for pulmonary vein isolation and AFib ablation. You know where the energy is gonna go.
You can predict the shape and the volume, and the size of this waveform, this energy delivery zone. You point this, and because of some of the features of the way nano PFA works, you can deliver a deep lesion, and you can deliver a circumferential lesion all within five seconds. The device is working extremely well in our preliminary clinical studies in Prague. You see procedure times for the total ablations on the order of 10 minutes or so, with multiple users. I'll say with multiple users, not one single expert user. For those of you who are familiar with the electroanatomical maps, in the right portion of this screen are all, they're not selected, all of the first 16 patients that underwent a remapping about two to three months after the procedure.
Couple of really intriguing elements in these remaps. The first, of course, is that the vast, vast majority of the pulmonary veins remain isolated. That's the goal of the procedure. The second is you can see how crisp, how crisp the lines are, right? This is because we're not ablating across multiple pairs of electrodes in multiple electrode positions, right? It's, it's a single, one-shot energy delivery to each of the pulmonary veins. And the third thing that I'll mention that's not on this slide is that if you compare these follow-up maps to the immediate post-treatment maps, there appears to be very little reversible zone of ablation.
And so what that means is that if you look at where you delivered the energy and where the cells are silent or quiet at the end of the procedure or immediately post-procedure, that seems to be where the line of ablation is chronically. That's a differentiator from micro PFA, where there tends to be a, what's called a reversible zone, where the amount of tissue that remains chronically isolated is narrower at follow-up than immediately post-procedure. We're really excited about the performance of the device. In summary, Pulse has a unique and differentiated approach to PFA, which has a long and strong scientific foundation, backed up by a very extensive intellectual property portfolio and know-how to deliver the nano PFA waveform. We're in clinical testing, early human testing with three different applications.
We plan to invest heavily in high-quality clinical data and follow regulatory paths that will lead to specific indications that we believe will allow us to, once approved, aggressively, penetrate in these different, markets. With that, I'll stop. We've got 4.5 minutes left for any questions.
Okay, great. Thanks, Burke.
You're welcome.
Is this on? Okay, great. Great. Thank you again. Just a couple of questions on what you presented. You know, can you first walk us through the decision to pursue a PMA versus the 510(k) for the surgical clamp? I know originally, the company had stated it was going to do a 510(k), and just talk about the benefits that you see of that PMA pathway versus the cost and time.
Yeah, that's a great question. I'd be happy to do that. The preclinical data were just so compelling, so compelling, that we said to ourselves, to get a 510(k) approval with a general claim and to not be able to aggressively sell, market, and train, would put a cap on the ability of the company to penetrate into the market. And that by taking the route of developing a high-quality clinical study, a pivotal clinical study, in cooperation with the FDA, demonstrating the performance of the device and going on label, that while that might take longer and probably will take longer to get to the first commercial sale, once we have approval, we believe, based on the performance of the device preclinically, that we'll be able to very rapidly convert the market.
Those of you who are following what happened in endocardial ablation, and you see what's happened to a lot of the RF business once PFA was approved, we believe that nano PFA in our application in surgical ablation has the potential to do something very similar.
And when it comes to surgical ablation too, you know, PFA has taken off really well in the endocardial ablation, you know, pathway just because of the time benefits and improving cath lab efficiency. In the surgical setting, do you still get that feedback from users of if this makes it faster, I could do more cases? Can you just explain, will you still get the exact same type of time benefit, essentially?
So we're really privileged to have two well-known cardiothoracic surgeons as part of the team, and a lot of what I'm going to say is feedback from them. Time matters, especially when patients are on pump. If the device is not only fast, but easy to use, and every time, the first time when you go to deliver the energy, you have a crisp transmural lesion, they believe that it will lead to more adoption of the use of this kind of ablation, especially in the concomitant setting, where you're adding in this in addition to something else, like a CABG or a valve replacement.
That makes sense. And then also just on the clamp itself, I know you did your first two first-in-human cases. Just feedback from those so far, how long did they take? And just the benefits that the surgeons saw during those first two cases.
Yeah, we really haven't given. It's just two cases, so we haven't given out a lot of the specific data. But I will tell you that the device performed very well, as it did in the preclinical lab, that the procedures were fast, that the patients did well, and that everybody in the lab, in the operating room, was incredibly excited about the way the device performed.
And then on the catheter ablation side. It's interesting that your device is going larger, because I know a lot of the newer studies today from the public companies and PFA are focused on point-by-point ablation, now bringing those devices to market, too. So how do you think you're gonna differentiate yourself, especially as those the PFA catheters are all moving to point-by-point?
That's a great question. So when I was interviewing and considering joining Pulse, I said to the team at Pulse, I didn't want to jump into, I call them the PFA wars. There are 20+ products under development, and what I needed to see was the potential in this energy and the way it's being delivered to be better, and I think I took a very sober view of how hard it was gonna be to be better. It's hard to be faster than the first gen PFA devices and the second that are under development. It's hard to be safer. It's hard to exceed some sort of chronic clinical cap of, let's call it 85% one-year efficacy.
But I believe that this device absolutely has the potential to be better than what's out there, and I think the reason that no one in the micro PFA world has designed a catheter like ours is because you can't. And I'm out of time, but I would love to tell you why I think it's gonna be better. I'll just take another 30 seconds. So if you can have it, if you can predict where your field is gonna be and where you're gonna have lesion, and you integrate this 360 catheter with a navigation and mapping system, and you point it at a pulmonary vein, you can tell the user before they deliver energy, basically where they're gonna have a lesion. You don't have to scrunch the catheter. You don't have to fold over the electrodes.
I don't have to deliver eight energy deliveries in a pulmonary vein. I'm delivering one, which means that there isn't cardiac movement, respiratory movement, movement of the doc's hand. You know where the energy is going, and then if that lesion is consistently there, chronically, you have a very, very easy-to-use tool. You could show somebody where the lesion's gonna be, they fire, and you could have a lot of confidence that you're gonna have a circumferential and transmural lesion there. I think that is a real differentiator in this space.
Got it. Thank you very much, Burke.