Good morning. Thanks for joining us again at the 24th Annual Needham Healthcare Conference. I'm Mike Matson, and I lead the MedTech and Diagnostics Equity Research Team at Needham & Company. I'm pleased to introduce Pulse Biosciences, presenting from Pulse. We have Paul LaViolette, Chairman, President, and CEO, and Jon Skinner, CFO. They're going to give a presentation on the company, and then we'll open it up for questions at the end. If you do have questions you'd like to ask, you can submit them electronically through the conference website, or you can email them to me at mmatson@needhamco.com, and I will try to fit them in. With that, I'll turn it over to Paul.
Thank you, Mike. Very much appreciate our longstanding relationship and your support of us joining this conference. As Mike said, my name is Paul LaViolette. I've got a 45 year track record in medical devices. I joined the board of Pulse Biosciences last year and found the technology and markets and clinical potential to be extraordinary. In the process, decided to join as Chief Executive Officer, which I did earlier this year. Jon Skinner joins me. Jon is our Chief Financial Officer, and we're looking forward to sharing our story about the company with you and answering questions as we go. Jon, we've already looked at the forward-looking statements. Our mission is to solely focus on Nanosecond Pulse Field Ablation and to harness it and deliver its therapeutic value. This is a technology that offers an extraordinarily wide array of chronic disease therapies.
It has all of the newly learned benefits of Pulse Field Ablation that we're now beginning to see in the electrophysiology market to treat atrial fibrillation. We have many additional and proprietary advantages based on our position in the nanosecond range of energy delivery. We'll spend some time describing that. We believe we are in possession of a revolutionary energy form that has multiple clinical applications. We're excited to be building out that platform through the clinical stage and now entering the commercial stage in 2025. Next slide please, Jon. I'd like to include a quote here from Dr. Niv Ad. Dr. Ad is perhaps the most published cardiac Surgeon in the world. He also happens to have recently joined Pulse Biosciences as Chief Medical Officer.
His view is that nsPFA has the potential, because of the qualities of the energy and how it affects tissue, to replace all other energy modalities in clinical use. In the process because of its qualities, adding speed, adding safety to procedures, enabling less invasive alternatives to surgery every application has the potential to expand the number of patients treated in respective markets. It has the potential to lower the interventional bar, increase market sizes, and disrupt market positions. We are extremely pleased by what we've seen with the technology. Dr. Ad's commentary, we think, nicely characterizes the potential that Pulse Biosciences brings to respective markets. Next slide Jon, please. If you think about our current financial position as of the end of the fourth quarter, we were in a very strong cash position with well over $100 million cash on hand.
We believe that provides the company with a multi-year runway to execute our clinical trial strategy, as well as to scale our commercialization efforts in our first go-to-market initiative, which we'll describe. That is a launch into a relatively new but large and untapped market to treat benign thyroid nodules, or I should say, as the first use case for our soft tissue ablation clearance. We have in addition to the cash runway, a historic burn rate for 2024 of $36 million. We expect that burn rate to increase based on the activities that I just mentioned, commercialization and clinical support of several investigational clinical activities. However, even with increased burn, as I mentioned, we expect our cash runway to reach two+ years. We have very strong investor support. I'll describe our board in a few minutes. We are very pleased with our current position.
We have the resources necessary to execute our near-term business strategy. Next slide please, Jon. Here is a quick look at the team, and I'll just spend a minute further introducing myself. As I mentioned, I've had about 45 years in medical technology, had about 30 years running businesses, including as Chief Operating Officer of Boston Scientific, where I spent 15 years helping to build that platform company. In addition, have been a venture capital investor in medical technologies for the past 15 years. I have a very deep experience with new markets, exciting new technologies, all facets of the medical device industry. I have seen a lot of very compelling technologies over time and find Pulse to be absolutely irresistible in that regard. We have a very strong team.
Darrin Uecker our Chief Technology Officer, has been with the company for a decade and leads our operations, research, clinical, and regulatory teams. Kevin Danahy, Mitchell Levinson, Chief Commercial and Chief Strategy Officers, who are really defining our market opportunities and our market entry strategies. Jon Skinner, Jon joins me today. Jon recently joined the company as Chief Financial Officer. We're very pleased to have him, and he's making a remarkable contribution early in his tenure with the company. I think it's very important to highlight that we have invested in and added the experience of multiple Chief Medical Officers, all of whom are world-renowned in their respective specialties.
This I think, defines both our conviction to have clinically oriented development programs but also describes I think, the magnetic pull that Pulse Biosciences represents to leading physicians who find the clinical potential of Nanosecond Pulse Field Ablation to be irresistible and for which they would love to have a role and impact our development and clinical strategies. We have a remarkable board of directors led by Bob Duggan. Bob, of course, is a legendary entrepreneur and investor, a serially successful builder of businesses. With Bob, we have a team of individual business leaders who have been incredibly successful and I will say, are remarkably, for my experience remarkably engaged in our business. We benefit greatly from their routine support. Next slide, please, Jon. Just a few minutes on the development of the company.
We're now seeing, we all, in the medical device marketplace, the emergence of the use of P ulsed Electrical Fields to ablate tissue. That of course, is defined now as Pulse Field Ablation. That field has emerged clinically and commercially in the last several years, principally in the Electrophysiology space, although this energy can be applied in many many areas. PFA has evolved itself. I would characterize the PFA that we see in today's market as first generation. That first generation resides in the microsecond or one millionth of a second pulse duration category. Nanosecond PFA changes that dramatically. We lower our pulse duration by an order of magnitude. With that change come many clinical and technical advantages, which we'll spend a few minutes talking about.
As a company, we really are the byproduct of several decades of work, including a decade 20 years ago at the university and basic research level where Nanosecond PFA was created. Pulse Biosciences, over just the past 10 years or so, having invested approximately $400 million to develop the technology and the first applications, were the beneficiary of over 1,000 publications on nsPFA as an energy form. We have de-risked the company by advancing our platform through development into the FDA clearance process, have achieved seven clearances. Our most recent device, which we'll describe in a minute, has also achieved a breakthrough designation with the FDA. We really feel as if we are a young company emerging into commercialization, but with remarkable foundational strength that is reflected in a proprietary platform that is protected by over 180 issued patents, with another over 100 pending.
A very proprietary system of delivering P ulse Field Ablation Energy from the generator all the way through to a series of applicators to treat multiple clinical indications. Jon next slide, please. Just to give you a sense of our market opportunity, the number of markets that we're currently pursuing, and how those create market potential for our team and for our company, we currently are focused on three areas, which I'll describe. Those three today invite the potential of about $6 billion of market potential for Pulse Biosciences to pursue. We have large markets today, but those large markets actually are growing significantly based on our ability to penetrate those markets, our ability to expand globally over time.
We believe our addressable markets with just our addressable market potential with just these three categories will expand from the high single-digit billions to the mid-teens billions, $15+ billion over the next handful of years. That is based upon three markets that I will describe. The first one is based on a soft tissue clearance from the FDA, the first use case of which will be to treat benign thyroid disease. I will spend a little bit of time talking about why that is such a dynamic business opportunity and a remarkable clinical application. Our second would be to enter the cardiac surgery market to treat preoperative atrial fibrillation. This is a very exciting market. It exists today. It is underserved technically by radiofrequency tools, and it is certainly underpenetrated as a result. We will describe that in a little bit more detail.
Lastly, but the largest of them all, the Electrophysiology market to treat atrial fibrillation. We all in medical technology markets, we all see this as a dynamic new category. It's been, of course, one of the largest interventional cardiovascular fields for a long time. The underlying incidence of atrial fibrillation is growing. The procedural rates and volumes of treatments are increasing at double digit rates. This technology is undergoing really, or I should say this market is undergoing a technology transformation with the first as the first arrival, if you will of PFA to treat patients. Our sense is that this combination of markets provides us small, medium, and large opportunities where we can create new market value, we can expand existing markets, and we can upend current large entrenched markets. We feel that provides the company with a wonderful array of commercial opportunities.
We will describe how we are going to go about that in just a minute. The next slide gives us a little bit more of an overview about Pulse F ield Ablation. We are, of course, seeing and hearing and reading about PFA because of its impact on the EP space. What we are really seeing is a transformation from the use of alternative hot or cold energies that destroy tissues into a conversion with the use of Pulse F ield Ablation to produce non-thermal tissue destruction. This allows for the conversion of not only this particular field of EP, but really multiple fields where extreme heat or cold is used currently for the destruction of cells. We believe Pulse F ield Ablation has the potential to address many of those markets with better clinical outcomes while dropping right into the existing workflow currently used by interventional physicians.
The result of faster energy delivery, the result of non-thermal therapeutic potential allows for increased throughput more procedures, increased efficiency in the healthcare delivery process, and importantly, greater safety because we're not introducing heat extremes that propagate uncontrolled within tissue beds. While we see great potential across multiple markets, we also have to recognize that today in the commercial application, what we see is really first generation of PFA energy. What Pulse Biosciences will be bringing is a next generation of pulse electric field application to multiple markets and with significant clinical benefits, we believe. Next slide Jon. This just gives one more view of what differentiates Nanosecond Pulse F ield Ablation from current applications using microsecond.
If we think about the engineering difference between these two, what we're really thinking about is dramatically shortening the pulse duration, which is to say how long that pulse exists in the tissue. The shorter we can make that pulse, the lower the likelihood that it will leave any heat behind in the tissue. With a reduced amount of heat potential, we can use higher amplitude in our waveform to produce greater clinical effect while remaining a completely non-thermal treatment. We think this really produces substantial clinical benefits. Those clinical benefits translate over to, as I've mentioned previously, safety and ease of use. The most important element of what Nanosecond PFA delivers , is that it is non-thermal. It can be applied to the tissue without raising the tissue temperature. We believe our energy, as a result of how it's delivered, can produce deeper lesions.
In many cases, we're looking, depending on the treatment application, to create a full thickness or transmural lesion to complete the most effective ablation. We also introduce an entirely new mechanism of action, which we believe will improve healing in patients and reduce what is left behind if you will, in the form of scar tissue. Lastly, current PFA systems tend to deliver energy that is picked up by nerves. Those nerves send that energy to the surrounding muscles, which cause patients to have involuntary movement during treatment. That can increase the required anesthesia level to paralyze patients and prevent involuntary motion. nsPFA does not produce that same form of muscle stimulation. That produces a significant upside potential for our application. In addition, by having a novel energy, we are allowed to create novel catheter forms.
Our catheters tend to be more flexible, easier to use, more clinically friendly, if you will. All of that creates a system from end to end that is proprietary and clinically advantaged. With that, Jon, let's turn to the next slide and just talk a little bit about how we manage the breadth of this platform opportunity. As mentioned, we're going after multiple markets, some of which are very large and entrenched, some of which are new. We are looking to bring as many applications to commercial stage as we possibly can. We realize that commercializing a platform of multiple markets is very difficult for any company to do.
What we're trying to do is create a hybrid business model by identifying certain markets that, based on criteria related to competitiveness or based on the magnitude of the entry barriers or capital efficiency of entering, we can enter certain markets with a direct business model. We will enter other markets that are larger and more complicated through partnerships. This hybrid business strategy allows us to pursue multiple markets while preserving capital efficiency in our operating model and still accessing as many patients and delivering as many therapies to the market as possible in the shortest amount of time. With that, we'll go to the next slide and begin to talk about these market opportunities one at a time briefly. The first market opportunity that we're pursuing, as I mentioned, is the thyroid benign thyroid nodule market.
That is a market that is today supported by our first clearance in soft tissue ablation and will commence commercialization activity in 2025. If we look at how this market is constructed, what you see here is approximately a 250,000 per year patient diagnosis rate. Of that 250,000, approximately 150,000 annually undergo benign thyroidectomy, which is to say removal of the thyroid in order to eliminate the symptoms associated with thyroid nodules. In addition to the 150,000 undergoing annual surgery, another 100,000 choose to avoid surgery, but really have no treatment alternatives. Therefore, they go into a watchful waiting pool that has built up in scale over time to in our estimates, at least a 2 million patient waiting group.
If you think about annual incidence and surgery conversion, you think about drawing from a large watchful waiting pool, we believe there is a very large patient population here that can produce a $1 billion market opportunity that Pulse Biosciences would uniquely pursue. The real benefit here is to spare the thyroid, to preserve this critical gland that produces hormones controlling heart rate, body temperature, blood pressure, and metabolism. Today, those 150,000 surgeries remove that vital gland solely for the purpose of reducing symptoms from a benign growth. The patients are understandably quite reluctant to have loss in that bodily function solely for the purpose of reducing the volume of a growth. Jon, let's go to the next slide and talk a little bit about what this technology does.
Nanosecond Pulse Field Ablation can reduce the nodule size and spare the thyroid gland itself while not touching, not disturbing, not endangering the adjacent critical structures of nerves and blood vessels that closely surround the thyroid gland in the neck. nsPFA as we've talked about, is a non-thermal energy. It does not introduce heat in this zone. It ablates the tissue without leaving a scarring effect behind, which unfortunately is caused today by current treatment forms. We produce a significant symptomatic relief by reducing the size of the nodule, taking the compressive forces symptoms off of the patient's neck, and doing so without surgical intervention and leaving behind, as you can see in these images, leaving behind an area that over time looks as if it never was treated and has really been restored to completely normal appearance and most importantly, underlying normal function of the gland.
Next slide Jon. If we think about the status of this, as I've mentioned, this is now, fortunately for us, FDA cleared and we're beginning to move into the commercial phase. We're completing a 10 center, which is currently underway, a 10 center 100+ patient clinical study to gather evidence in support of adoption and reimbursement. We're transitioning this program from early pilot stage, if you will now into commercial. That transformation will take place throughout the course of 2025. We'll begin to accumulate our first commercial experience with this platform in the conversion of those clinical centers over to commercial and then the expansion of that commercial footprint from those first 10 centers up to our target of 40+ by the end of this year.
We're working to fortify claims to build clinical evidence and really create a first-mover market for Pulse Biosciences in this very large and significantly underserved market and clinical population. Jon, next slide. The next opportunity that we'll talk about is in Cardiac Surgery. This is for the treatment of patients undergoing Cardiac Surgery for what could be coronary bypass or mitral valve repair and in whom Atrial Fibrillation already exists as a preoperative condition. Imagine a patient going in for open heart surgery and already diagnosed and suffering from AF. Our job now is to find a way to treat those patients of their atrial fibrillation concurrent with the open surgery they're undergoing for their primary concern. This is a very large market. There are about 300,000 annual open heart surgeries, of which approximately a quarter or over a quarter present with AFib preoperatively.
Despite the treatment of these patients for AF being current guideline directed therapy, only about a third of those patients actually receive treatment in the form of concomitant ablation during their surgery. This is the opportunity we believe we can both enter and then subsequently expand dramatically. The current market is about 80,000 patients, but only as I mentioned, a third currently receiving treatment. We believe that that low conversion rate of patient treatment is directly attributable to the limitations of current technologies, including principally R adiofrequency Ablation. In the process of converting RF to Nanosecond Pulse Field Ablation, we believe we can produce dramatic improvements in clinical effectiveness, drive utilization up, and really create a market that first converts to Nanosecond PFA and then becomes a much larger market because the clinical benefits would drive increased utilization.
To look at our status, we'll go to the next slide. Here you see that we're developing a tool that will be used in the image on the lower right-hand side during open heart surgery. The surgical clamp that you see produces an energy field between those two edges. That surgical energy field produces a clean, non-thermal, very rapid ablation zone that can treat atrial fibrillation extremely quickly. Speed in this instance is exceptionally important because these patients are on cardiopulmonary bypass. As we all know, pump time is exceptionally critical and has to be kept to an absolute minimum. The benefit here of nsPFA producing full-thickness non-thermal lesions to allow the completion of ablation procedures, we think, can be highly enabling to the fulfillment of the goal here, which is to treat AF in patients while they're on the table undergoing cardiac surgery.
Next slide, Jon. To give you a sense of where this program resides, it is currently in a clinical phase. We've completed the first arm of our feasibility study. We're seeing very compelling clinical evidence. We've used our evidence to date to apply to the FDA and have received breakthrough designation and are participating in the regulatory TAP program, the Total Product Life Cycle Advisory Program, which essentially provides us real-time review with the FDA. This program will move into its IDE pivotal study in the United States in the middle of this year. We have very high expectations for the clinical results that this will produce in the quarters ahead. The last one next slide Jon, is the largest opportunity of all and perhaps the most dynamic market today. That is the use of Pulse F ield Ablation to treat atrial fibrillation.
It's the best early example of PFA's potential. While we're seeing a remarkable dynamic and positive dynamic in the AFib market, I think it's really important to note that the clinical benefits of first-generation PFA are limited relative to existing RF ablation. Overall, clinical efficacy is around equivalent. While safety is beneficial, we think there is significant upside potential that next generation nsPFA can deliver in this market. You know about this category. It's extremely large. It's growing very rapidly, sustained double digit growth, exceeding $8 billion in time, multiple millions of patients, and increasing diagnostic burden of AF in our population. We think this is an absolutely vital area for PFA and one that represents significant clinical potential for Pulse Biosciences.
To take a look at our program on the next slide, you'll see how we're engineering a significantly different device that produces not spots of ablation, which current catheters produce, but actually full circumferential and transmural rings of tissue ablation. This is a revolutionary delivery of energy, really substantially improves upon existing PFA platforms. This is a technology that would drop right into the current treatment workflow, produce deeper lesions, produce faster lesions, produce non thermal clinical benefits, and has the potential to be used, of course, during the core procedure of pulmonary vein isolation, but also to be used more broadly in the left atrium for a more diverse array of AFib patients.
On the next slide, just to give you a little bit of a sense of how our technology would feel and work in the clinical application, we have only one catheter required to treat the pulmonary veins and the left atrium. We can produce a single lesion in a five second burst of energy. We do not require multiple catheter manipulations or multiple catheter and electrode rotations. There is a significant reduction in the manipulation required by the physician. Total procedure time is dramatically reduced, with ablation time dropping by two-thirds down to just a few minutes, 10 minutes, 10 to 12 minutes is what we're seeing in our clinical cases. Because the nanosecond PFA does not capture nerves in the same way that microsecond does, we are able to treat our patients with lower anesthesia burden overall.
This is potentially a very disruptive technology entering a market that has already shown its willingness to rapidly convert when a technology with disruptive potential is introduced. On the next slide, just a very quick anecdote, and then we'll wrap up. This is an example of a first case done in Belgium a little bit earlier this year. This is a physician who had never used our system before, did not undergo significant training, and produced pristine isolation in just a matter of 11 minutes or so. This is supportive of all of the clinical experience we're seeing across Europe. Very high isolation rates, very fast procedures, very little interventional and fluoroscopic imaging time. We feel very positively about how this system will perform on a larger clinical base. On the next slide, you'll see where we're leading with this.
This program will also enter an IDE in the middle of 2025. We are going to be pursuing a conventional, and now there are, of course, multiple companies that are pursuing this, a conventional paroxysmal atrial fibrillation indication. We presented data and demonstrated a live case display at the Boston AF Symposium in January. We'll be doing very similar updates with new data and cases in the HRS conference in San Diego in later April. As mentioned, we intend to be conducting our submissions and initiating the IDE for this technology in the middle of 2025. We think this is an extraordinarily attractive technology application for nsPFA going after an exceptionally large market that is ripe for change. Lastly, let me just conclude by summarizing and indicating that nsPFA is a novel energy.
PFA is performing extremely well, but nsPFA produces improved clinical benefits and improved workflow, improved safety profile for patients, and is a proprietary technology for Pulse Biosciences protected by over 180 issued patents and nearly that amount pending. We have mounting clinical evidence across multiple clinical indications. We are conducting multiple pivotal studies in 2025 and commencing our first commercialization launch. We have a strong balance sheet, a very strong team, an extraordinary lineup of market opportunities. We feel we are very well positioned to be a sole focused PFA player in multiple med tech markets going forward. With that, I'll close my comments. Mike, I'll turn it over to you.
Yeah, thanks. Just wanted to follow up on a few things.
I guess first, on the catheter ablation product, as we've done work in the space, it seems like there's this view that long term, there's going to be a desire to have catheters that can maybe do RF and PFA with a single catheter, as well as both offering catheters that can do focal ablation as well as single shot. I mean, is it your view? Do you agree with that? Is that something I know maybe you won't have that on day one, but is that something you could eventually incorporate into your technology?
I do not agree with that. We would not incorporate RF into our technology. I think it's really important to think about why anyone would do that. It is in pursuit of lesion depth.
Based on the proprietary elements of Nanosecond PFA, we achieve greater lesion depth with our higher amplitude energy delivery. These are novel elements of our platform and would completely eliminate any need to consider integrating what I will now call antiquated RF energy into the PF generator. There would be no need to hybridize and complicate, frankly, the purity and the elegance of nsPFA with an RF energy. I do agree that in addition, although the 360 catheter tool that we have is exceptionally versatile, and we will evolve it to be even more versatile, there is value in having a focal catheter available. That is something that we are developing and is something that will be moving itself into human feasibility clinical work later this year.
Okay. And then just the trial designs for the surgical clamp and the catheter. Maybe you could just give us a quick overview there. Are those going to be would you ever consider doing a head-to-head versus the existing technologies with the FDA? I know when you get to sometimes when you get to a certain point where there's a lot of the products out there, sometimes they require head-to-head studies. I'm just curious what your thoughts are there.
Yeah. For the catheter for endocardial ablation, actually, the protocols are relatively well established with FDA. They are single arm studies, so nonrandomized, really just comparing to an objective performance goal based on published literature. They're actually not substantially large studies, under 250 patients enrolled to achieve a Paroxysmal AF indication. The surgical clamp, in effect, is a comparative study, but it's randomized in general against non-ablation. You have an ablation arm, a non-ablation arm, and you see how those patients perform.
I have conducted many head-to-head studies over time. I think in our case, we're not looking to do that, certainly not in the near term. We think our clinical performance will be very strong. We think the evidence will separate, if you will, even though it's not generated in a direct comparative design. Usually, head-to-head studies are done later in the market uptake of technologies like this. If we were to do a technology to demonstrate our likely superiority against other platforms, we would do that later. I think our evidence early on will be quite intriguing, even in the absence of any direct comparisons within clinical trial designs.
Okay. Just last question. You've got the in terms of non-cardiac applications, you've got thyroid that you're going after, a benign thyroid lesion. Is there any other potential uses there? I mean, is there could it be used to treat cancerous lesions anywhere in the body, for example?
Yes. Great question. The answer is yes to both. We do have, quite frankly, a building and long and impressive list of next clinical opportunities. We're very focused in 2025 and 2026 on the three that we've described here, although we will be expanding that list. We will be describing to our investor base our strategic plan in the coming years and how those markets will be added to. Malignancies, cancers are clearly within our mindset. We are initiating in the latter half of this year some research to explore probably as an immediate adjacency thyroid indications. Remember, our first application is benign thyroid.
Our goal would be to try to assess within that same clinical bed, within that same market channel, the same endocrine surgery operator base, whether we can expand to treat malignancies of the thyroid. That is something we are in the very early stages of now, and we will spend more time in the future talking about that.
Okay. Great. I think we are out of time. Thanks for coming to the conference. I hope you have some good meetings.
Thanks very much, Mike. Our pleasure.