Good morning, everyone. My name is Ana Runcie. I'm one of the med tech associates here at Piper Sandler and today I'm pleased to introduce Pulse Biosciences. Speaking, we have the CEO, Paul LaViolette, and he is going to give you a little overview of the business, so I'll turn that over to you.
Thanks for that introduction, and good morning, everybody. It's my pleasure to be here on behalf of Pulse as the CEO and Co-Chairman. I've been in the med tech space for the better part of four and a half decades. I've had a chance to work on a number of extraordinarily exciting technologies. PFA, of course, has been a resounding new theme in med tech in the last couple of years. Nanosecond PFA, which is what Pulse Biosciences offers, produces extremely short, billions of a second pulses at extremely high amplitudes, but yet delivers less overall energy in the process, and we think the potential of that technology combination is extraordinary. It addresses multiple large markets. It produces disruptive therapies for very large unmet clinical needs, and I found, despite all of my experience, that this technology was irresistible.
As a result, I have been committing to leave this company for the last year, and it's making extraordinary progress. I'll make some forward-looking statements today. Just a quick comment on our mission. With a technology like this, it truly is a platform technology. It produces life-altering therapies, and it gives us a tremendous opportunity to build a great company. We have a mission to build a thriving, viable company. We think that is going to be defined by persistent growth over time as we enter market after market. We think that's defined by extremely high margins in the med tech space. We think that's defined by exceptional clinical value. We think that's going to benefit physicians and payers, providers, and obviously patients. Ultimately, the value here is to Pulse investors. We have a tremendous amount to look forward to.
Just a quick look at the history of the company over time. PFA as a field has been around for several decades. Nanosecond PFA has been in development, I'd say, for about a decade. The company has been tracking that timeline for about 10 years, about $400 million invested in creating this proprietary technology base. It is a field, nsPFA, that is backed by over 1,000 publications. So there's very little question about the viability and validity of this technology. Dozens and dozens of those publications are specific to our company. We now have seven FDA clearances. We have a breakthrough device designation. We're in our first IDE. We have a first platform being commercialized. So as it relates to progress, and I will call it de-risking of the story overall, we have made fantastic progress. PFA is a space that multiple companies can participate in, as you have seen.
However, the next generation of PFA, Nanosecond PFA, is covered with really a moat of proprietary protection. We have 215 issued patents. That's up 35 over the last year. We have another 100 pending. So this is a story that is backed by real capital, tremendous IP, a growing body of clinical evidence, which we'll talk about in a bit. But ultimately, that IP protection allows us to control the generation and delivery of nanosecond pulses for multiple therapeutic applications. And we find ourselves, we believe, in a unique and protected position to deliver a unique and new therapy in a broader field of PFA, which is obviously very hot in med tech. Our team is highly experienced. As mentioned, I've been doing this for about 45 years. 30 as an operator, 15 as an investor, associated with many important technology launches and many new markets of significant value.
Our team has a lot of operating experience, is very deep with technology development. We have an outstanding technical and clinical team. We've been supported in the last several years with key opinion leaders, chief medical officers that are helping to lead us in each of our clinical arenas. And so it's a wonderful team that's come together to support a truly unique technology. We have a very impressive board led, as many of you know, by Bob Duggan. Bob is co-chairman of the board. He's a serial entrepreneur, a legendary investor, and a major supporter of our company. So we feel we have a fantastic position to really launch this technology into its maturity. From a financial perspective, we have a strong balance sheet. We ended Q3 with $95 million in cash. Compare that to a $36 million burn for 2024.
That burn will increase as we fund two IDEs and a commercial launch in 2025. We have the capital required to run this program and really produce really important clinical, regulatory, and commercial milestones. We have very strong inside ownership and have just begun posting revenue, which will, of course, grow from this point forward. Just a minute on two themes here. One, the mechanism of action. I should turn my phone off just in case. Two, really the differentiation of our PFA. Mechanistically, I think everybody is aware. What's unique about PFA is that it initiates cell death non-thermally. That's the goal here, replace all thermal interventions, of which there are millions, with a non-thermal alternative. Nanosecond, of course, does that uniquely with pulses that are measured in billions of a second duration.
So very high bursts of energy for a very short amount of time, delivering less total energy to the cell and to the tissue, leaving no thermal footprint behind. And in that process, allowing a unique mechanism of action. We're actually causing the cell to enter a regulated cell death process. So the cell essentially dies in a normal process, does not signal to the body that it's been harmed, introduces a non-inflammatory-based healing process, and that cell that had been unwanted in the past, either causing an arrhythmia or causing an unwanted growth, is eliminated. The regulated cell death process is unique to nanosecond PFA. And importantly, because it only affects cells, we do not damage nerves or blood vessels, which are acellular, even if they're intimately surrounding the targeted tissue.
That mechanism of action is unique on a cellular level, but what really matters is how this translates into practice, and so, again, the goal here, non-thermal delivery, you can ablate repeatedly with our technology in the same location, and you will find no spread of temperature at all. In fact, you'll find no temperature rise in the tissue in the area that's been treated. We deliver less overall energy. This is extremely important. Our ablations are deep and fast, and importantly, we do not really capture nerves. What that allows is for procedures to be done without general anesthesia and paralytics, which allows you to move procedures closer and closer to the outpatient setting, and overall, the lower energy burden through our catheters allows our systems to be extremely flexible and easy to use in various applications.
With all of these potential benefits, we then look at the various markets that we're approaching, and we'll talk about each of these three in particular. Thyroid is our first, where we're going to create a new interventional treatment for 250,000 newly diagnosed benign thyroid patients per year. Cardiac surgery is an established category. Ablation is used today, but it is not commonly applied, even though it is guideline-directed. And we think we can expand that market significantly. And of course, EP, the largest market of all, we've seen that grow dramatically. It's been disrupted by first-generation PFA, and we believe second-generation PFA has the same disruptive potential on that current market as first-generation PFA had over radiofrequency ablation the first go-around. Our markets today, the three that we're targeting now are worth $6 billion.
We think those will expand over the next couple of years based on incremental penetration and globalization to over $16 billion, and we will have a pipeline of incremental therapy targets beyond that. With that many markets to attract or to attack, we cannot do them all ourselves. We've got a hybrid business model. We're going to take technologies that we believe can be brought directly with capital efficiency, with low market resistance, with low competition. We'll do those ourselves, and thyroid is a great example of that. For markets that are very heavily resourced, that would require very high capital investments to launch, we believe a partnering strategy is more efficient, and we will use partner in those instances. EP is a great example of partnership. Thyroid is a great example of go direct.
And there will be other markets that will fall in between, and we'll make strategic decisions for those based on individual circumstances. First and foremost, thyroid, this is a critical organ. It produces hormones that control blood pressure, body temperature, heart rate, metabolism. And yet, for a benign growth, the current practice in 2025 is complete surgical removal of the gland. And that should be viewed as categorically unacceptable in this modern era of healthcare. As I mentioned earlier, 250,000 annual diagnoses, 150,000 go to surgery. We think that creates a billion-dollar opportunity. This is really a white space. There's no competition to speak of. This is thyroid sparing. So patients who undergo our therapy will retain their thyroid, and that thyroid will have preserved functionality. If you think about exactly how this is performed, it's ablation.
It's very minimally invasive, a 1-millimeter insertion site, a Band-Aid when you're done, and symptomatic relief within two weeks, elimination of the volume that has grown. So elimination of the structure itself, symptom relief, and thyroid preserving at the end. So it's an exceptionally attractive alternative to the 150,000 thyroidectomies that are performed, as well as the multiple millions of patients that are currently under surveillance, diagnosed with symptomatic benign thyroid nodules, and unwilling to undergo a current treatment. So we think we can pull from the watchful waiting pool and convert thyroidectomies. Current status, we've initiated commercialization. We commenced a limited market release earlier this year. We're expanding that gradually. We're finding very impressive uptake. We're trying to drive increased utilization per site and, at the same time, driving clinical data with a series of post-market studies, which we'll report on over the months and quarters ahead.
Very exciting new market there. Cardiac surgery, an existing category. As I mentioned earlier, underused principally because of the limitations of radiofrequency ablation. These are patients that already have atrial fibrillation when they go into the hospital for open heart surgery to have bypass or valve repair or replacement. That's a 300,000-procedure surgical opportunity, of whom over a quarter already have AFib, and yet only 30% of those AFib patients are treated today because of the limits of RF, and we believe that market can be expanded dramatically based on the benefits of nsPFA and ultimately expanded into a prophylactic therapy since a significant percent of patients post-operation will develop postoperative AFib. Our therapy is undergoing an IDE right now, and we've done feasibility work in Europe that's been published at recent cardiothoracic surgery meetings. Our lesion sets are exceptionally fast. We make a lesion in 2.5 seconds.
Our total ablation time for a procedure is as short as 50 seconds total compared to 30 to 60 seconds to make a single lesion with RF. It's highly disruptive. We're very pleased with our progress. The IDE has commenced. As I mentioned, this is a Breakthrough Device Designation in the TAP program within FDA, and we will provide updates on our data, both from European feasibility results and this IDE in the year ahead, and then lastly, the largest market of them all. Everybody's familiar with AFib ablation, the single most common arrhythmia. This is a market that's been growing based on increased diagnostic incidence, increased, let's say, conversion of drug use into primary frontline therapy for AF, and that's been driven by PFA, and we believe we can drive that yet again with a next-generation therapy that dramatically alters the workflow and safety profile of AFib ablation.
Our ablation times are five seconds in length compared to 30 seconds or longer for other PFA systems. Our total ablation times are at 10 minutes or, in our most recent studies, as low as five minutes compared to half an hour for leading companies. And our lesion set is significantly improved over what we see today from current competitors who have dramatically altered utilization in PFA. And our system is compatible with multiple mapping systems. From a status perspective, we have filed for our IDE. We're in active discussions with FDA to have that IDE approved. We expect to be commencing our enrollment of first patients in the next couple of months. And we think we're sitting on an exceptionally disruptive technology here that can do to PFA and EP what PFA did to RF in the last couple of years.
To summarize, it's an exceptionally novel energy form that is patent-protected with a very strong vault of over 200 issued patents and another 100 pending. We think we'll be the sole practitioner of nsPFA in multiple areas. We have growing clinical evidence in multiple clinical specialties and multiple studies underway. We've initiated commercialization in our first indication for thyroid, which is a field that does not have competition. The market values that we're targeting are currently multiple billions and capable of growing substantially beyond that. And we have the balance sheet to execute on that plan through 2026 and expect to put a lot of points on the board in the next year. And so with that, I'll close my comments and happily answer any questions with time that remains.
Hi, Paul. Josh Jackson suggested you do give the impression you're talking about. How do you think you compare to Cardium type of organization?
Well, Cardium, for those who don't know, is a recently FDA-approved platform that integrates mapping and ablation using PFA. And so the first thing I would say is that their business model is predicated on dislocating a mapping system. And that mapping market is exceptionally established and entrenched. So that's a disadvantage, in my opinion. Second, it's a very large, I'd say, unwieldy device operating within a relatively constrained space of the left atrium, which is not ideal. Third, I would say, if you really step back and say, "What's driving growth in AFib?" It's pulmonary vein isolation. Cardium is really focused on their ability to map and then ablate. But pulmonary vein isolation is not a mapping-centric procedure. It's an anatomically driven procedure that is mapping light in many ways.
So if you were to say, "Find me a technology that is ideally positioned to capitalize on the principal growth driver of pulmonary vein isolation," personally, I would say Cardium is not it. Okay. Thank you very much.