Morning. Really excited to have Pulse Biosciences up here presenting for us today. From the company is Kevin, who is the President and CEO of the company, and I will turn it over to you.
All right, thanks, Matt. I really appreciate it. So my name is Kevin Danahy. I'm the President and CEO of Pulse Biosciences, and thank you for attending our investor presentation. This is just our forward-looking statement. Nanosecond pulsed field ablation. CellFX nsPFA. I want you to think back when you first heard the word robotics, and what paradigm shift took place when you heard that word. Did you lean in or did you lean back when robotics was launched?
And if you could go back in that time and think about what you did and what you would do differently today, that's the paradigm shift that I'm talking about with nanosecond pulsed field ablation in CellFX. There has been major advancements in articulation, in access, and visualization over the last 30 years, but very little movement when it comes to energy, until now. We are that paradigm shift.
We are going to make a significant difference, and I'm going to explain to you today the difference between nanosecond and microsecond, because most PFAs are out there, and there's a lot of energy and noise around that. We're going to talk about what the difference is. And what's really exciting for us, if you want to get involved with this energy, we are the only pure play in a publicly traded company if you're excited about this energy, and we think we're going to make a significant difference.
We know we are. So this is our leadership team. Our leadership team has great success launching disruptive technologies over the years, led by Darrin Uecker and Mitch Levinson on my team, and then a board of directors with Bob Duggan and Maky Zanganeh, whose successes in pharmaceuticals and in med device are second to none.
But the people I want to focus on today is Dr. Gan Dunnington and Dr. Niv Ad, joining us as our Chief Medical Officer and our Chief Science Officer. We're super excited that these guys had the opportunity to join our tech, technology and our team. They went into the lab and they saw the technology, and after firsthand experience with it, they were so excited that they asked to join our team and give up 50% of their clinical opportunity. I think Dr. Niv Ad said it best. He saw the technology and he stepped back and he said, "I'm not easily impressed, but now I'm inspired. This technology will change cardiothoracic surgery forever." And we have that same belief, and we know we're going to take it to that level.
So let's talk about AFib and why we believe we are the right company to change the entire market, this $8 billion opportunity. We're going to do it with our proprietary technology. That's an easy word to say and a harder word to understand, right? When you say proprietary, what it means is that you have ownership and accountability for the knowledge to bring the technology to market. We have 15 years of accumulated experience with this energy and technology, and we took all that energy and we brought it into one console, and we took it into one company. And then we said, the console has to be safe and effective to hold this powerful energy, and we built it.
And then we built the connectors and the end effectors, the proprietary end effectors, in order to take that energy and deliver it to tissue to get the appropriate tissue response. That's not easy. That's why we believe we separate ourselves from any other company that's in this space, is because we have the knowledge and accountability to bring this to market. And this is commercially viable and ready right now. We are not a startup.
We're not in a position where it's wires hanging out of the box. It's polished and ready to go. We also have an amazing strategy around IP, and it began right with the energy. We protected the energy, we protected the console, we protected the connectors to make it safe and effective to wheel it into an operating room, and we protected it to the end effectors.
The end effectors are designed specifically to take that energy and apply it to tissue to get the appropriate tissue response. You cannot take our device and take an RF product and plug it in and get the same effect. Just can't happen. Our strategy is a fortress when it comes to IP, and it all happens because we have broad medical expertise that have been down this path over and over and have the ability to take it through.
Let's talk about AFib in total, right? Some people want to separate this out and say surgical. The other people want to say it's electrophysiology. We say it's one market. Just listen to the radio, right? Everyone's talking about AF, atrial fibrillation. Everyone's saying, "How do we..." Pharmaceuticals are going, everyone's going after it.
But we want to go after it as one market, and we want to attack it from the surgical side, and we want to attack it from the electrophysiology side. Now, let's talk about the surgical side. There's some great companies in this space. They've been working at it for 10 years, more than that, and they've been going after this at a 30% penetration. 30%. So why did the adoption stop? It's simple. It's an equation that goes across all med device, across everything.
You have to show you're reproducible, you have to show you're teachable, and you're better than the existing technology. They have failed to do that. That's why they're stuck, right? The masses are not adopting this technology right now. They're stuck at 30% because the average person does not want to compromise the safety and efficacy parameters.
They will not push efficacy to compromise safety. nsPFA is going to change that paradigm. We're going to change the ability for doctors to do that. We believe this market is much bigger than what they're even thinking right now. We believe, and we know from our doctors, Niv and Gan, that they've told us that there's about 2 million cardiothoracic procedures done every year globally.
They also believe that if you touch the heart for any reason, you should be treating for AFib. More and more literature is coming out every single day to say, "If you touch the heart, treat," because if they don't have it now, they'll have it in the future, so get in front of it. We believe in that, and we believe we can make a significant difference in this market. Let's talk about the catheter side.
There's a lot of people talking about PFA right now. The big companies are all over it. We believe we have something substantially better. We have a single-shot product, 5- seconds, complete circumferential ablation. Time matters. That's what we're gonna bring to the market, and let me tell you the difference between nanosecond and microsecond.
Nanosecond is significantly better, in our opinion, because it's 500x shorter, and it's 20x less energy into the tissue. So we're not seeing that architecture side effect to all the surrounding, you know, vessels or ligaments or anything, or muscles and nerves. That's why we believe our impact is on both sides.
If we go out and do what we're gonna do, then we're gonna take the market in the surgical, and we're gonna show people that it's safe and effective, fast and efficient, and it's gonna accelerate adoption because of the ease. Then we're gonna take that momentum into catheter. And we believe that it more and more of the EPs are working with the thoracic surgeons, and they're looking at this from a hospital approach, and we'll be the only energy that will be effective on both sides. So let's talk about our advantage of the clamp and the catheter.
We're only about improving outcomes with patients, right? We have a novel energy. We think that's amazing. We think it's significantly different than what's in the surgical space and what's in the EP space, right? Our end effectors are specifically designed to receive that energy, apply it to the tissue, and get the appropriate tissue response, and we will have high clinical differentiation when we see it, our clinical results. But I'm gonna tell you this: every second when you touch the heart matters. Every second matters.
That's what's been preventing adoption. Doctors know that when they add time to cases, doesn't matter what the outcome is, it's scary. It's scary for the patient, it's scary for the hospital, it's scary for the physician. With our results, when you put our clamp on the tissue, 1.25- seconds. Full thickness transmural ablations, regardless of tissue type and regardless of fat. That is going to instill confidence. You look at the catheter, 5- seconds, no repositioning, complete circumferential ablation.
That's going to change both of these fields. That's gonna bring people in droves over here because adoption is not gonna be limited. People are gonna be willing to put their patient on a off- pump for 1.25- seconds, for 5- seconds. We believe that we're gonna explode both markets and go from zero to the lead overnight. So let's talk about the clamp.
The clamp, the device is ready. The console is ready. The clamp is through preclinical work. We are now putting all our information together, and we're getting ready to submit for a 510(k). That will happen sometime within the next several months. Let's look at the tissue, the clamp itself, and I'll make it personal for a second. It's tough when you have investors and bankers, right? But I'm gonna say, what if it was your heart?
What if you were sitting on the table, and I could tell you, instead of 30- seconds and multiple burns on the heart, I could do it in 1.25- seconds? That's gonna change the paradigm for these surgeons. It's gonna allow them to have the confidence to make the ablations that they want to make, and they're gonna be able to treat more and more patients.
We're really excited about our IP about around this. We're really excited about our outcomes. So why are we going into this market, right? We believe it's 2 million patients that we can go after easily, right? We think we can take this from 30%- 60%- 70%- 100% adoption because why is adoption stalled? Because they haven't shown it's reproducible, teachable, and better than existing technology until they get their hands on CellFX and nsPFA.
We know that our product offering is superior. We know that when people come in and they see our technology, they have what's called a jaw-dropping moment. Other companies have come in and seen our technology, other doctors come in, and they can't believe it's real. They can't believe what we're doing and the possibility of the outcomes that we're getting.
We believe that we're the complete solution, and we believe this is a sizable market, and not only that, by the time we come out with the catheter, there'll be thousands of people that have this. They'll already be treating in the hospitals, and they'll have the confidence with the safety and efficacy of nsPFA, and we'll take that confidence right into the catheter market. So let's talk about our catheter real quick. We believe it's second to none.
We will have the confidence of nsPFA out in the market. It is a single-shot, single-shot, five-second ablation on Pulmonary Vein Isolation. We will have more products that are coming out for the complete procedure, but this is what we have today, and this is highly differentiated because, again, we're 500x shorter, and we're the 20x less energy in the tissue, which means you're not getting that muscle contraction.
You're not getting the side effects and complications that other PFA companies are struggling with today. Their results have been good, but they've been a little bit underwhelming. We're gonna change that paradigm. We're super excited that we have no thermal energy, and we are excited about what we're gonna be able to bring into the market. So much so, everyone knows Mount Sinai. That's the rite of passage for big companies, right?
In order to bring PFA to the market, they go to Mount Sinai, Dr. Vivek Reddy. We did, too... He was so excited, they were so, so excited about our technology that they went to HRS and they presented three posters on our behalf, talking about tolerance and effectiveness, and tolerance and safety. And they will be working with us as we go to Europe and do our first-in-human trials. So where are we? We have accelerated development timelines. I'm excited to report this. We reported these last week. On the surgical clamp, I can tell you we are absolutely going to submit for a 510(k) sometime in December or January. So that is moved up from first half of last year, next year, to the first quarter. We're moving it up again.
On the catheter, I will tell you that we're booked and ready. We're going to Europe in December, and we will be doing our first feasibility study, and we'll be doing first in human. Those are accelerated timelines because of the team that we have and the product outcomes. Last, I'll just talk to you about the versatility of our product. Our product is an energy, just like robotics. It came into the market, and it's like, where can't you use it? That's where we struggle a little bit. Where can't you use it? It's a massive paradigm shift. We actually did a feasibility study over in Italy on thyroid, 'cause we wanted to do a proof of concept of our energy in human tissue internally. The results were so overwhelming, we enrolled the first phase, we've gone to phase two.
Now, I can tell you all about this. This market is going to be huge. 800,000 people have their thyroid removed every single year. That's their last treatment option, right? 20% of those are cancer, so over 600,000 are still benign tumors. Right? And that's what we're going after right now. On top of those numbers, you have people that are getting RF, where you stick a probe in and you hope for a 60%-70% reduction in six months to a year, but there's still a necrotic ball there. When we treated in our patients, there was complete resolution with no necrotic ball within 90 days. Some of them were even earlier than that.
The best story I can tell you is when an Italian woman tells you she hasn't been able to eat spaghetti for 10 years because of the way her tumor is going into her esophagus, and then she said after two weeks, she could eat spaghetti, that's a game-changing moment. You have more of those cascades over and over in the patient outcomes, I believe they're going to be lining up in droves for people to come in and have this procedure done, and we're going to be the company to deliver it. So in conclusion, where are we? I'm super excited to let you know, we will be revenue generating in two out of three of our product lines in 2024.
When it comes to the clamp, we are submitting our 510(k), and it will be submitted sometime in December of this year or January of next year. When it comes to the catheter, we're heading to Europe, and we're doing our first in humans, and we're excited about that. And we already announced that we submitted our 510(k) for the perc electrode, and we did that in November. So just to finish this all up for all of you, I led with robotics, I'm going to end with that. Did you lean in or did you lean back? And how would you have changed your response and how you present to the people that you talk to? This is that lean-in moment.
This is the opportunity for you to make a significant difference in patients' lives and the people that are around you with CellFX nsPFA. This is a paradigm shift. No one has what we have, and it's protected with a fortress. It's now time to lean in and join us. Thank you very much.