Welcome to our 45th Annual Growth Conference. With us next, we have Pulse Biosciences, and we have Paul LaViolette, CEO, and Jon Skinner, CFO. This will be a presentation format, if there's any time, we'll have a Q&A at the end. With that, hand it over to Paul.
Thank you, Bill, and great to be here at Canaccord once again. As Bill mentioned, my name is Paul LaViolette. I'm CEO of Pulse Biosciences. I've been in the medtech space now for 45 years. I've been associated with a number of innovative new technologies, market launches, frankly, therapy transforming technologies. I became aware of this company and the therapy platform, nanosecond PFA, and I found it irresistible, to be honest. I joined the board as of a year ago. I became CEO in January, and it's been a wonderful ride. I think we have a very exciting future. We will be making forward-looking statements today.
Let me just fill you in on our mission. There are really a couple of key points here. One is this is about life-changing therapy. This is a therapeutic platform. We're going after a number of different markets, which we will articulate, and we can do important work such as curing AFib. You think about treating a patient with paroxysmal AF. You can take that patient out of AF and really cure them of that disease. Similarly, with something like our thyroid indication, you can cure that patient of their symptoms from benign thyroid nodules.
This is a life-changing therapeutic platform company going after multiple diseases, and our mission is to build a thriving, viable company. When I think about thriving, I think about high margins. I think about fast growth, sustained growth over time based on new market opportunities. I really think about, in our case, five Ps. It's about the patient, it's about the provider, it's about the physician, it's about the payer, and ultimately, Pulse Biosciences participating with all and making, frankly, a better outcome for all of those constituent markets, if you will. A little bit just about the history of the company and what we do.
This is about creating and delivering pulse electric fields. We all hear about PFA, and of course, the most recent dynamic with PFA, with Boston Scientific disrupting the EP space, that's the most manifest display, if you will, of the energy. The secret of the business, if you will, broadly, is using pulse electricity to ablate tissues non-thermally, to not have to deliver heat in the form of, let's say, radiofrequency or microwave or high-intensity focused ultrasound, to not have to deliver heat to create ablative effects. PFA is relatively new. It's obviously been impactful if we look only at the EP dynamic in the last year.
I want to think out loud about the differentiation of PFA. Not all PFAs are the same. If you think about that pulsed electric field, one of the most important variables is how long that pulse lasts. The longer it lasts, the greater the chance for delivering thermal energy and the increase in the total energy delivered. What we're trying to do is decrease the total amount of energy delivered and decrease the proximity or the risk of delivering any kind of thermal footprint. The secret to Pulse Biosciences is the creation of the delivery of the control of pulse duration into the nanosecond range, which is another way of saying we measure the duration of our pulses in billions of seconds. A ll other technologies measure their pulses in millions of a second. Now, they both sound really fast, but bear in mind that there's a thousand-fold difference between pulse durations of millions or billions of a second. By reducing that duration, we get to drive our amplitude of energy higher, and that creates remarkable clinical benefits.
We'll talk about some of those in a minute. The company has been around now for about a decade. It's obviously publicly traded. We have invested almost $400 million of capital in the development of this technology and our clinical applications. We have a trove of preclinical data. We have a very impressive, I think, array of intellectual property governing the creation and delivery of those very short duration pulses at high energies. We have multiple FDA clearances already in hand. We have breakthrough designation on new indications. We really do think in the overall wave of the delivery of PFA for clinical indications that we sit on the best energy.
We possess the best energy, and we possess it in a proprietary way. We have a very strong team, a lot of operators, a lot of market experience, a lot of technologies already delivered to the market, a lot of experience in energy, in energy delivery, and in ablation markets overall. Very strong tenure. I was very pleased to join this. As I mentioned, I'm a veteran as a function of my white hair. You can tell I've been around, spent 15 years at Boston Scientific, spent 15 years as a private equity investor on multiple boards. I've been on, I think, 25 boards in the medical device space. I've launched maybe 50 new technologies, some of the biggest in market history.
I generally have a sense for important clinical opportunities when they come along. We're supported by a fantastic team of engineers and clinicians. We have three really influential Chief Medical Officers across our span of clinical opportunities, and I would say a legendary board led by Bob Duggan. Bob is, of course, a serial entrepreneur, a legendary investor, and frankly, a brilliant mentor for myself and for the company. We're in a very favorable position as a team. Financially, we reported our results just yesterday. We think we have a very strong balance sheet.
We certainly have the cash with a little over $100 million at the end of the quarter to execute our plan, which in that plan is very focused on running two IDEs, which we'll describe momentarily, as well as an expanded pilot launch of our first commercial indication, which we'll also describe in a minute. We have a very strong start, if you will, to a company that is building a platform and pursuing multiple indications. Let's talk about Pulse being a different entity. As I mentioned briefly a minute ago, PFA is a very popular and very dynamic technology today. That's a very good thing for us. The important distinction here that I've previously characterized is that nsPFA is not the same as what we hear about from other companies with PFA. It's really important to understand these differences, not to memorize them, quite honestly, but to really understand that this is a differentiated platform. It makes deeper lesions, which is critical if you want transmural ablation, let's say, through the full thickness of the cardiac structure. We deliver less energy overall. That substantially improves our ability to create non-thermal lesions.
Remember, the whole purpose of introducing PFA is to avoid the increase of tissue temperature in the process of ablating tissue. It's really important to understand the mechanism. PFA introduces cell death by creating electroporation in cell membranes. That is key to affecting tissue results without introducing energy. Without going into all the details, I will simply say that by hastening, by making swifter pulses, and by increasing our total energy delivered, we can have a greater effect on cell structures than other PFA platforms. Importantly, since our pulses are in the body for such short amounts of time, they are not picked up and creating neuromuscular stimulation. As a result of that, patients can undergo procedures with lower sedation requirements and non-paralyzing anesthesia, which obviously enables procedures to be done in less intensive sites of care. Overall, we think we're in possession of a very novel form of PFA that fundamentally changes our position competitively in various markets. As a result of that novel PFA energy, we are going after, or have the ability to go after, multiple markets, and we've targeted three initially.
The first is really to go after the creation of a thyroid intervention market. We'll talk about this. Thyroid is not a clinical target that many, let's say, investors have heard about. Frankly, not that many companies participate in the thyroid therapy delivery space. Yet, it is a very significant disease. It has significant clinical effects, and we think it's a wonderful greenfield opportunity for nsPFA. The second, cardiac surgery, where there is an existing ablation opportunity, which we expect to be able to expand. It's underpenetrated today. If you look at those three markets, of course, the EP ablation market is extremely large. That creates a $6 billion set of market opportunities for us today. Those market values increase to more than double that over time based on market expansion and expanding from the U.S. footprint to a global footprint. There is no shortage of addressable market value for Pulse i n the array of markets and certainly just the first three that we're targeting. Now, because we're a platform company, it would be very difficult to go after many markets simultaneously. That creates for us a strategy of having a hybrid approach to markets. We are being very focused on capital-efficient market entry.
Therefore, we will take on markets in a direct fashion where we believe they are addressable, where we can enter the market and do so efficiently. In those markets where there is already a very large established footprint of competition, we will more than likely partner. We have a hybrid strategy. We'll take some direct, we'll do some via partnership. Some of those will be obvious. EP is an example of an obvious partnering opportunity. Thyroid, we think on the other side, is an example of an obvious direct opportunity. There will be, I'm sure, others in between. We will look at those one- by- one over time to determine our approach. We think this makes for a capital-efficient approach overall for the company. It allows us to focus on key priorities and to build value without trying to, let's say, expend exorbitant amounts of capital reproducing clinical infrastructure. With that, let me move on to the first indication, which is thyroid. Thyroid is a remarkable category for us and one that we think has enormous potential. The thyroid is a gland. It produces hormones. Those hormones perform critical functions in our body. They control body temperature, they control heart rate, they control metabolism.
With benign nodule growth, with the growth of a benign set of cells within the thyroid, we end up having to take the thyroid out with surgical removal because it is so difficult to deliver energy. You have critical functioning surrounded by critical structures that make delivery of energy challenging. As a result, a surgical removal of a critical organ. I would say that is unacceptable. Our mission with our first indication with the benign thyroid nodules is to convert a surgical removal of an organ into a less invasive alternative. If you think about this category, 250,000 patients annually diagnosed in the United States with symptomatic benign thyroid nodules. The prevalence is much higher. As much as 50% or 60% of the population have growths in their thyroid, but they're relatively small and tolerable. As they grow, they need to be addressed. Of those 250,000, 150,000 ultimately lead to surgical removal, 100,000 go into watchful waiting. It's our challenge as a company to convert those surgeries importantly to a less invasive alternative and make that so relatively attractive that patients who are on the watchful waiting list refusing to undergo surgery because they want to preserve their thyroid gland and its function, that we can begin pulling those patients in and create a flow of the watchful waiting pool into current treatment. What we offer by way of nsPFA is a thyroid-sparing procedure. Bear in mind, these nodules are growing within the thyroid. They may affect thyroid function.
Obviously, thyroidectomy removes the thyroid, forces a patient into hormone replacement, and is generally a poorly tolerated alternative. What we're trying to do is create a non-surgical alternative, a minimally invasive approach that reduces the mass, eliminates the symptoms, and preserves thyroid function for that patient over time. That is a very attractive new clinical indication for not only us as a company, but for a very large underserved patient population. If you think about what we ultimately deliver for that patient and that physician, they have a minimally invasive alternative that, through the delivery of non-thermal ablation, preserves adjacent nerves, including the nerves that control the vocal cords, preserves adjacent structures such as the esophagus and the trachea, and allows an endocrine surgeon to offer a non-surgical alternative to that patient. Because it's non-thermal, unlike RF, it does not produce a scar inside the nodule that would leave a knot in the patient's neck, even as the volume of the growth is reduced.
What we're seeing with our patients is the reduction in that growth and the elimination of symptoms in as little as 30 days following the procedure, with a reduction in volume and improvement in cosmesis for those patients, but frankly, leaving the therapeutic zone so relatively benign that they really can't tell where the intervention took place. This is a very important and impressive therapy delivery. This is cleared under our 510(k) for soft tissue ablation. We are in an active pilot today. That pilot is moving into a limited launch over time. We're in about 10 centers now. We expect to increase that significantly. We're producing clinical data. We're producing reimbursement processing. We're producing concentrated critical mass centers in geographic targeted cities. We're executing this launch in a really controlled way because there's no alternative, there's no competition, and we really want to launch this right, build a great foundation for a market that can be quite sizable for Pulse in the years to come. We are very enthusiastic about this. It's our first indication. The second indication is cardiac ablation. This is an area that already exists as a limited market.
We think it's significantly underpenetrated. It's a market that is treated today with radiofrequency, and we think highly amenable to the clinical benefits offered by nanosecond PFA. You're familiar with this to some degree. Patients undergo open heart surgery for bypass or for valve replacement. That happens about 300,000x a year. A significant percentage of those patients have preoperative AFib. It is within the guidelines that those patients should have ablation because they already have AFib and they're already on the operating table. Those patients are only treated for their AFib about 25%- 30% of the time, which tells you that the majority of patients are not receiving that therapy because the time commitment or the reliability of the result derived from radiofrequency ablation is inadequate to be added onto the surgery in the judgment of those surgeons. What we're trying to do is offer an improved therapy that would not only replace current radiofrequency ablation, but would expand the market to include more of those patients who are on label, but not currently receiving the treatment. This is a significant market today.
That market expansion is available immediately because those patients are already indicated. There is a subsequent market expansion that could be made available with subsequent studies in the event that we can treat patients prophylactically for a very high incidence of postoperative AF. That's a longer story. The point is this market is available. It deserves to be converted to nsPFA. In so doing, we can substantially increase market penetration and over time significantly expand the market. This is a technology that is similar to what is being used today, the use of a bipolar clamp. We replace RF with PFA. Our PFA is capable of delivering a full thickness ablation in a matter of just a few seconds. A single ablation leads to a full thickness transmural lesion, which of course produces a block to electrical conductivity and the elimination of an arrhythmia. Because this is non-thermal, it's very safe for adjacent tissues. The goal here is to add time to the surgery, but as little time as possible. These patients are on cardiopulmonary bypass. We want to minimize the time required to add ablation while making the elimination of AFib something that can be routinely achieved following normally scheduled, if you will, open heart surgery.
This platform is undergoing an IDE. We have submitted the IDE. It's a breakthrough device designation, part of the TAP program within FDA. We expect to receive approval on that IDE in the next several months and to commence a pivotal study to initiate the approval process for this technology between now and the end of 2025. Lastly, we'll just talk about the EP market. You already know it. It's the largest market of those that we're pursuing. It has been transformed in the last several years with the initiation of PFA therapy. PFA has added a speed and safety factor to this market, making it one of the most attractive areas for nsPFA.
We believe nsPFA can add significant value on top of first-generation PFAs that are already available in the market. I'll just give you a sense of how that would be delivered. If you think about today's delivery of PFA, we're still delivering point lesions and rotating catheters to have overlapping points, delivering as many as five to eight sets of lesions in each vein. The average time to do that is about 30 minutes of ablation time. If you think about nsPFA, we have a larger energy delivery footprint. Our lesions are created in five seconds. We only need to deliver one, maybe with a second. Two five-second lesions per vein, creating total ablation time for PVI in 10 minutes or less with experienced operators. We know that our lesions are deeper. Yet, despite that, we do not capture the nervous system and create unwanted muscular stimulation. Overall, we think this is a really disruptive energy in a market that has shown a strong affinity to adopting disruptive energies. If you think about status for this platform, we also have, with this program, submitted an IDE that's currently under interactive review.
We expect to receive approval for that IDE in the coming months and to also commence our pivotal study in the United States between now and the end of 2025. We've produced data on this program that are very impressive and indicative, I think, of a real advance in the treatment of AF with a next-generation PFA. Just to conclude, this is a very novel platform company. We have proprietary ownership over a next-generation PFA energy. That next-generation PFA energy has multiple target indications. We're producing very impressive clinical evidence across that array of indications. We're adding to that with multiple IDEs in the coming year. We have very large target market opportunities, some of which we'll pursue with partnerships, some of which we'll pursue directly. We are in possession of a strong balance sheet that enables us to execute on that plan in 2025 and 2026. We're very excited about the potential that Pulse Biosciences possesses. With that, I'll conclude my comments.
I would love to ask a question. You know, your reputation procedure, you've done this a long time, and you kind of came out of basically the VC world to take this on.
You were going to say retirement, right?
No, you were not retired. You were never retired. You know, I look at this and you've got a lot happening. I mean, this is a lot for a small company. I'm just so, what I'd like to do is just focus on the thyroid. You've got a soft tissue. You're going to market with this. How important will clinical data be to drive adoption? I think you also mentioned you need to work on reimbursement. Those are two big hurdles for a small med tech company. Just kind of walk us through how fun do you think it's going to be to really knock those down and how much traction can you get before those are kind of knocked down and out of the way?
Yeah, so very good question. I think let's take data first. This market is like so many other markets. There are tiers, if you will, of approachable physicians. There is a top tier, which we're going after now. We would identify that top tier as being as many as 200 sites where you have high-volume endocrine surgery. They are doing hundreds of thyroidectomies at those centers. They are already trained in ultrasound-guided therapy, whereby they have assimilated skills to use RF ablation, but they virtually across the board do not use it.
If you think about the setup for early adoption of 200 accounts, you can do that with relatively small resources because there's no competition. We're the first to offer a bona fide alternative. This is a young patient population. They are trying to preserve their thyroid, and we are giving them an alternative to surgical removal. The market entry dynamic here is low resistance. I'll turn it over to the reimbursement question. There are existing codes for irreversible electroporation, IRE. Those codes allow for this therapy to be coded. Thyroid is not an existing indication for those codes, but multiple organs are approved on those codes. We are initiating pre-authorization and/or predetermination for the use of thyroid ablation in those codes. That is, I'll call it the reimbursement challenge. We have data published from our first in a man series. We have new data coming at the American Thyroid Association next month. We believe we have enough data to both satisfy any insurer who is looking to substantiate the payment of these procedures, as well as that first and second tier of physician groups that are looking to adopt what they now understand is a very safe therapy with PFA for those patients who might have been eligible for RF ablation. They felt RF wasn't safe, but they really want to avoid taking that thyroid out. We think we have a very large addressable market near term with the data we have and with the reimbursement process that is already underway.