Good morning. I'm Josh Jennings from the TD Cowen Medical Devices Research Team. We are excited to have executives from Pulse Biosciences participate in the conference for the first time. I'm going to introduce a veteran in the medical device space whose career we have admired from afar, and we're excited that he has joined Pulse Biosciences as the co-chair and CEO, Paul LaViolette and the Chief Financial Officer, Jon Skinner, is joining us in Boston as well. I'm going to hand it over to Paul to present. It's a pleasure to have you, Paul. Great to see you.
Josh.
Thank you, Dr. Jennings, I should say. As Josh mentioned, I'm Paul LaViolette. I'm the CEO and co-chairman of Pulse Biosciences. It's a pleasure to be here today. I've been in the medical device industry for 45 years, run a number of things, been associated with many new technologies, many exciting marketplaces. It is with that in mind that I found the technology of nanosecond PFA and the core value of Pulse Biosciences to be irresistible. As Josh mentioned, I am chairman of the board. I've been on the board for about a year. I stepped in as Chief Executive Officer at the start of 2025. It's one of the most exciting technologies I've ever had the privilege to be associated with. I'm looking forward to sharing that with you today. To advance the slides. I will be making forward-looking statements today.
This is our disclaimer. I just want to spend one second on our mission. We do intend to build a very thriving, viable company. A lot of early-stage companies focus on, let's say, building value and quick exit, becoming a tuck-in story for a strategic. We think we have a tremendous platform value here to share with multiple clinical specialties. The therapeutic value of nanosecond PFA is vast and will go after multiple clinical conditions and chronic diseases. We think nanosecond PFA is a very unique energy and has remarkable therapeutic value. Our focus is on building this company, initiating commercialization with our first platform in the next year, concurrently initiating multiple clinical studies in other fields, which are equally exciting and, in some cases, substantially larger, and building this platform out to be a really unique story in the medical device industry.
I'd like to start my talk off with this quote from Dr. Niv Ad. Niv is one of the most prominent cardiothoracic surgeons in the world, certainly among the most published. He described nsPFA as an energy that can replace all other energy modalities in medicine. Obviously, he's focused on cardiac ablation. I'll give you more insights into the cardiac surgery field specifically. His thought is that this is disruptive. It's transformative for the patients he serves. We'll describe that in more detail. Not only is it potentially capable of changing the way patients are currently treated, but substantially expanding the number of patients that can be treated. That is because you end up with improved safety, improved efficacy, substantially improved procedure flow, speed of intervention, overall efficiency in delivering therapy.
That brings into therapeutic targeting far greater patient populations than we see treated today in many of the markets that we're targeting. We will describe that in more detail. We really think this nicely characterizes the potential that Pulse offers. Pulse is a very strong company today. We have multiple programs in the clinic. We have achieved multiple FDA clearances. We have a very strong financial outlook. We have a balance sheet as of the end of December 2024 that showed $118 million in cash on hand. Pro forma earlier in Q1, that was $130 million following final receipts from a rights offering that was conducted last year. That provides us with a multi-year cash runway. Our burn in 2024 was approximately $36 million. That burn will increase in 2025 based on our embarking in multiple clinical trial activities that I'll describe in more detail.
We have ample cash resources to conduct our clinical work and our commercialization activity over the next several years. We have very strong inside ownership, which is indicative of fantastic commitment and conviction for our technology and for the clinical mission that Pulse Biosciences is pursuing with nanosecond PFA. Speaking of that conviction, we have a management team that has just been recently expanded with the addition of Jon Skinner. Jon is our Chief Financial Officer, has excellent MedT ech credentials with fast-growth companies like Imperative Care and strategics like Teleflex. We have a very strong senior leadership team. Chief Commercial Officer, Chief Technology Officer, Chief Strategy Officer, Kevin, Darrin, and Mitch are deeply experienced, decades of senior management and even Chief Executive Officer experience across multiple companies deep in our space of energy delivery.
I will say, as I joined the company, certainly, in addition to the technology and the number of markets we could pursue, the quality of the leadership team was a major draw for me. I started in MedTech leadership in 1980. I led the first interventional cardiology business in the United States. I've been associated with growth platforms for decades, having started at Boston Scientific when it was a relatively small company and staying there for 15 years and helping to lead its growth up to $8 billion when I retired. I've been a MedTech venture capital investor for the last 15 years. I've been on a couple of dozen medical device industry board of directors. As I mentioned at the beginning, my excitement about Pulse is based on, frankly, a very high expectation for therapeutic value.
I've seen some of and been associated with leading some of the largest market-creating strategies in MedTech history. I think Pulse has the potential to be a very exciting addition to those chapters. I think it's extremely important to emphasize that in addition to a very strong management team, we have an array of prominent chief medical officers that have joined our company on a part-time basis, leaving portions of their practice time behind to help us work on applications of this disruptive therapeutic energy into their fields of practice. We're really blessed to have great clinical minds. It also shows the commitment the company has to developing great clinical science to go along with our energy applications. We have a fantastic board of directors, that board is anchored by Bob Duggan and Macky Zanganeh. Bob and Macky are legendary serial entrepreneurs.
They've built fantastic companies. They've created tremendous amounts of value. I would say they are legendary investors as well. We have a very active and engaged board supporting a very strong management team. I just want to spend a few minutes giving you a perspective on nanosecond PFA. It's an energy that has been under development for probably about 20 years, starting perhaps for the first decade or so in academic research as energy pulses of electricity were tailored and reduced in duration from milliseconds, thousandths of a second, to microseconds, millionths of a second, then into this entirely new space on the spectrum of nanoseconds. Measuring pulse durations in the billionths of a second time duration. I'll go into more detail as to why that's important.
In very short form, by reducing the duration of the pulse, you are reducing how much energy is delivered and therefore how much heat is delivered. If you can reduce the total amount of heat associated with that pulse, you can drive its amplitude up and improve its therapeutic potential while not leaving any thermal footprint. That creates both novel clinical mechanisms, but also significant technology differentiation from other companies practicing pulse field energy delivery. This is a field that has developed and been substantiated by over 1,000 publications. The company, our company itself, has invested $400 million to date developing this technology and its clinical evidence. That has led to seven FDA clearances, our most recent having earned breakthrough designation at the FDA and a proprietary position for this energy, which I think really sets this company apart. We have over 180 issued patents.
We have another 100 plus pending. That really allows us to stake claim that this energy is proprietary. Unlike many energy forms that have preceded us, which become open market and commonly practiced and generic, we believe we will own the ability to generate and deliver nanosecond pulses of PFA for years to come. Let's talk about market potential and where we're focusing our management energy and resource. We have multiple large markets to aim at now. We are developing a list of additional indications beyond this list of the first three that will keep us busy for years to come. That target list of markets today creates upwards of $6 billion of real-time potential. Those markets, as we look out to 2030 and expand globally, will produce target value for Pulse Biosciences exceeding $15-$16 billion.
We are not short of target market potential. The first indication for commercial use will be the thyroid application, which falls under our soft tissue ablation approval. That is an existing addressable market over $1 billion. We feel that can double in the relatively near term. The second one we'll go after will be cardiac surgery. That's for preoperative atrial fibrillation. Patients undergoing surgery already have existing AFib for whom that AFib could be addressed concomitantly with their cardiac surgery to correct other issues, whether it's coronary bypass or mitral surgery as an example. That's another $1 billion-$2 billion market, which also, based on growth and penetration and expansion, we believe could reach $5 billion-$6 billion in the next several years. Lastly, but the largest of all, is the EP Catheter Market.
That is the AFib endocardial ablation market, multiple billions today for ablation, more than doubling in size based on organic growth accelerating beyond 15%-20%. Very large markets, some of which we believe we can enter directly, some which we will partner. When you look at Pulse and nanosecond PFA, we think we can create new indications in markets like thyroid. We can substantially expand markets such as concomitant surgery. We can enter existing large dynamic markets and become a disruptive therapeutic innovation such as the EP Catheter Market. An array of opportunities for this business and this energy. A little bit more about PFA. You're familiar with PFA now in ways that we never would have been two or three years ago based on the launch of FARAPULSE in the EP Market. It's revolutionizing that category.
If you step back and look at why, it is because existing ablation markets, EP or other, have historically used extreme temperatures, either extreme heat as delivered by, let's say, radiofrequency energy or extreme cold for the purpose of destroying tissue. You can destroy tissue with minimally invasive approaches. You can avoid surgical intervention and take advantage of the energy's ability to disrupt unwanted tissue. That has created substantial market potential based on less invasive benefits, based on faster procedures, based on increased throughput in hospitals, lower recovery time. All of those are benefits of minimally invasive procedures with energy. They've been improved upon by first-generation PFA applications. What's important to understand about Pulse is that we will bring to the market those same benefits of PFA while substantially adding to that list of benefits by shortening our pulse duration into the nanosecond zone.
If we look at the specifics of nanosecond PFA and how that might alter tissue and alter clinical applications compared to conventional PFA, there's a list of reasons why our select nanosecond PFA will be substantially advantageous. Perhaps the most important is that by shortening that pulse duration, we can increase the total amount of voltage we deliver into the tissue. That change allows us to deliver substantially larger and deeper lesions. It eliminates nerve capture of the energy, which eliminates unwanted patient movement during intervention. Despite having more voltage delivered, we leave no thermal footprint behind. This is an entirely non-thermal method of ablating tissue. Because our energy or our voltage is higher than regular PFA, we do not specifically create electroporation at the cell membrane level, but rather inside the cell at the engines of cell vitality, such as the mitochondria.
We actually stimulate the formation of natural cell death or regulated cell death, which is a natural healing process that avoids the immune response and avoids a fibrotic response. This tissue is left as if it had not been treated at all, no history of heat or of thermal damage. It really is a fundamentally different way of treating tissue while using lower total energy delivery into the body. It is a result of that combination that we think nsPFA will be disruptive in multiple clinical applications. The company cannot go after every market by itself. Some markets are more attuned, if you will, to direct entry, and other markets are more attuned to partnering. We start with a business model that will be a combination of direct and partner.
Markets such as thyroid that are not deeply competitive and can be addressed with a capital-efficient commercial team, we will address directly. Markets that are larger, that are more entangled with different therapeutic support systems, such as EP, are likely to be approached by us via partnership. Let's look at our three markets and spend a few minutes on each. First and foremost is thyroid. The thyroid is a gland that produces hormones. Those hormones control vital bodily functions such as body temperature, heart rate, metabolism. Obviously, to the extent we can preserve thyroid function, that is the goal. For benign growth in thyroid nodules, it's extremely unfortunate that many of these patients undergo thyroid gland removal via thyroidectomy. 250,000 annual diagnoses, 150,000 of which convert into an open surgical removal of the gland. That's the principal target.
How do we avoid those surgical removals with a procedure that does not produce a scar and that leaves the thyroid in place and functioning? In addition to that 150,000 thyroidectomy volume, there are an incremental 100,000 that go to watchful waiting. Those two pools, therefore, represent patient flow into a less invasive alternative that is nonsurgical and thyroid sparing. We believe nsPFA is an ideal energy source to treat benign thyroid nodules in lieu of surgical intervention. Here you see a patient moving from baseline through therapy, one-month follow-up, 12-month follow-up. You see what we see typically in this patient population: no evidence of intervention, obliteration of mass, and a patient that is restored to normal thyroid function.
This is an extraordinarily safe procedure in comparison, as an example, to radiofrequency ablation, which in this particular zone where the thyroid is surrounded by critical nerve and vascular structures and the esophagus and trachea, it's vital to avoid thermal damage with uncontrolled propagation of heat zones, which is exactly what RF produces. We think nsPFA is a perfect energy for this market, which today is predominantly surgery. Today, we are FDA cleared to apply our soft tissue indication to the thyroid opportunity. We have a post-market study underway in 10 centers that will be completed in the middle of Q2. Those 10 centers will be converted into our first commercial sites. We'll supplement that early clinical work with additional studies, but we will principally be focused on a commercialization strategy starting mid-year and building rapidly throughout the course of 2025 and beyond.
First, plan for commercialization, thyroid nodules, and we will pursue that directly. Second is the Cardiac Surgery Ablation Market. This is an established market for, as I mentioned earlier, patients undergoing open cardiothoracic surgery or some other requirement besides AFib, but who are already diagnosed with AFib on board. About 28% of patients undergoing open surgery have AFib already. Of those 300,000 surgeries, 28% or about 80,000 patients are amenable and on guidelines today to receive concomitant AFib ablation. Only about 30% of those patients actually receive it. That is a function of the limitations of RF ablation currently used in surgery to treat AF.
We believe that the speed and the efficacy of nanosecond PFA has the potential to treat all, not just 30%, but all of those AF-indicated patients and to also open up an opportunity for prophylactic treatment of patients, a significant portion of whom will acquire AFib as a function of the cardiac surgery they're undergoing. There is a significant current and addressable market here that can increase the current surgical clamp opportunity by 3-5 to potentially 10-fold. If you look at our status, we are undergoing OUS feasibility study today. That will be converted into an IDE in the U.S. for commercialization in about 24 months. We think the benefits of PFA in this application are dramatic. This requires only about a three-second ablation, one time applied per line to complete isolation and to render patients AFib-free following surgery.
With that relatively rapid treatment, there's very little incremental burden for the surgeon or the patient who is on pump. As a result, we believe we can substantially expand the number of patients treated with no expansion of operative time or patient risk. Here, again, I alluded to this earlier. We've received breakthrough designation from the FDA. We're in the TAP program, which is an elite selection that provides us substantial resource and focus from the agency. We're going to be conducting a study this year. We expect the results that we're seeing in our feasibility study to play out in a larger controlled study in the United States.
Lastly, the largest market I alluded to, the EP Ablation Market, this is a dramatically larger market than anything else we're addressing, multiple billions today, and obviously a market that is possessed of double-digit organic growth, has the potential to become an $8 billion ablation market in the next several years. The diagnostic rate for AFib is increasing. We're seeing already dramatic effects of pulse field ablation in this category. We think the category can be revolutionized once again. You think about the relative comparison of our PFA, our nanosecond PFA versus microsecond PFA, the favorable elements are that we drop right into the exact same treatment paradigm. There's essentially no learning curve. We produce substantially deeper lesions. We dramatically reduce procedure time with an energy that creates a full circumferential lesion with a single ablation of only a few seconds.
We really require no change to operative norms for the electrophysiologist. If you look at how we would compare to an existing PFA system, as an example, on a per-vein basis, we would require only one or two energy deliveries versus four to eight for current practice. Total operative time would be reduced from an hour or an hour and a half to 30 minutes. Total ablation time would be reduced from 30 minutes to 10 minutes. This is a function of our nanosecond energy delivery and deeper lesion quality and depth. We think these are meaningful, clinically noticeable, physician-appreciated differences in energy delivery. They have the potential to convert into higher efficacy over time. We hope to see that when we conduct larger-scale clinical trials. This is a display of some of the data we disclosed at the AFib Symposium in Boston in January.
You see here with patients followed to three months, 92% isolation rates achieved in 11-and-a-half-minute treatment times and overall very short procedures. The image above is an example of a physician performing his very first nsPFA case. No learning curve, no experience with the technology in advance, and perfect isolation with 10 minutes of ablation time. We think this is a disruptive clinical result and is indicative of the kind of disruptive potential we have for this broader market. As with the clamp, the catheter is also undergoing completion of feasibility data. We're treating patients in an ongoing protocol in multiple centers outside the United States, planning to file our IDE and commence a clinical trial for this technology in 2025. We think this is a very exciting platform for Pulse Biosciences. In conclusion, we have a novel energy form.
Nanosecond PFA is unique in the PFA space, creates a novel mechanism of action, is surrounded by a wall of hundreds of issued patents, and is clearly a next-generation energy form. The clinical evidence we have is mounting in multiple clinical fields. We are conducting additional clinicals this year to advance our programs toward commercialization in the United States. We think the market value of the markets that we're targeting is multiple billion now, growing to $15 billion-plus in the next five years. That pipeline of current markets will be supplemented by a pipeline of future markets. We have yet to describe publicly what our next list of targets will be. We are working on a number of indications that we will bring forward in the next couple of years. As I said, we're initializing commercialization for the very first time with our thyroid indication within the soft tissue realm.
That will really convert Pulse Biosciences from being a development company stage to a commercialization stage company. We have a strong balance sheet with the cash reserves to execute the plan for several years looking forward. Thank you for your attention. I'm paid to Pulse Biosciences, and I'd be happy to answer any questions. Thank you, Josh. Yeah, the buzz, of course, it's hard to quantify buzz, but I would say buzz is very positive for a couple of reasons. PFA is doing well. Let's be honest. The FARAPULSE launch has been remarkable. It's achieved $1 billion of revenue thus far. It's really becoming the energy of choice. Yet, it's not perfect. There's still a fair amount of catheter manipulation.
Really, overall efficacy still remains around the same as we've seen historically with RF or cryo in that 65%-75% range for chronic AFib-free off antiarrhythmic drugs. There is room to grow in efficacy. There is room to grow in safety. With closer to 100 total cases performed, the data that we're seeing is really quite clean. Our safety profile looks outstanding. Our isolations look clean. The procedural times are very short. The ablation effectiveness, the energy as it addresses tissue and creates acute isolation is extremely impressive with almost no catheter manipulation, which allows a physician to enter a pulmonary vein, deliver an ablation for five seconds. If necessary, in their judgment, they can deliver a second ablation for another five seconds, and then they are done with that vein.
Just think about walking through pulmonary vein isolation to treat paroxysmal AFib in two lesions, two lesions, two lesions, and then you're effectively done with pulmonary vein isolation for an AFib patient with under 10 minutes of ablation time and probably five minutes of fluoro time. It really is remarkable. Even though the buzz in EP is compelling today because of commercial systems, the buzz in anticipation of this next-generation system, I would say.