Next up, we have Todd Usen, CEO of Adagio Medical. Thank you for being here, and welcome.
Thank you. I appreciate the time, and thanks for having me. Today, I'd like to give you a little update on Adagio Medical. My name's Todd Usen. I'm the CEO of Adagio. I'm lucky enough to have a great team. I became the CEO in December of 2024. 300,000 sudden cardiac deaths every year in the U.S. alone. The number one cause is VT arrhythmias. Adagio Medical has built the only purpose-built catheter for this large, very underserved VT ablation market. It's a $6 billion market. We've shared tremendous safety data, efficiency, and efficacy data of freedom from shock. We've treated patients all over the world. We have our CE mark in Europe. We expect to be the first purpose-built VT ablation catheter approved anywhere in the world in the fourth quarter of this year.
With that, we have a two-year both competitive clinically and commercial headstart. When I look at what we've done as Adagio in a short time, we've executed on each and every front that's been put in front of us. We've had a big last year. We have some major milestones ahead of us that we're looking forward to sharing, led by the 209-patient FULCRUM-VT trial, that we just shared their final data in HRS this past month. We also have our second-generation product that has been granted FDA IDE approval. We'll have two generations of technology before any other technology has one. Coming up this year, we'll have some great upcoming year-end opportunities to share some great data to the world. We are building value through real, achievable, near-term milestones. Like I said, it's a big market.
The market's really broken up into two major functions: structural heart disease, which is broken up into ischemic and non-ischemic cardiomyopathy, and idiopathic VT and premature ventricular contractions. It's a large market, but only 6% penetrated to this point. I'm going to share with you why. 15 years ago, if you went to see your physician with AFib, they would basically give you an antiarrhythmic drug. Studies came out that showed that AFib ablation was more effective than drugs alone, and AFib ablation has taken off with RF and PFA since. Similarly, today, with VT. VT ablation has been second-line therapy to drug therapy as well as ICDs.
Until recently, two studies were published, the VANISH2 and the PAUSE-SCD, which demonstrated that VT ablation is more effective than AADs, antiarrhythmic drugs, and ICDs alone as a first-line opportunity. Now the market is waiting for the right technology. Second major challenge. Every technology that's been used for VT ablation is a repurposed catheter designed for atrial ablations. Couple of key things, differences in the atria and ventricles. The ventricles have very thick myocardial tissue, whereas the atria is very thin tissue. Therefore, we need to have technology that goes deep for lesions, which forces physicians to not only do an all-inside approach, which is called endocardial, but they must do an epicardial approach, which is coming outside of the body. EPs don't always choose to do this technology, they refer this procedure out to tertiary centers.
Every patient that goes through an RF ablation and/or a PFA off-label is required to have irrigation. Heart failure patients, by nature, are fluid compromised. These patients are now staying in the hospital an extra one or two days with diuretics to remove that fluid, as well as other technologies that are given to the patient to reduce the chance of vasospasm, which leads to stroke. The nice thing about the vCLAS catheter purpose-built for VT ablations, the first VT catheter ablation technology, it has durable and titratable deep lesions. The key to this technology is it's all endocardial. No matter how deep the lesion is, we are doing nothing epicardial. We do everything in an endocardial approach, which opens up the market for every electrophysiologist that is capable of doing an AFib ablation can now have access to do a VT ablation. We address all VTs.
This is not just some VTs, ischemic, non-ischemic, idiopathic, et cetera. We've had great success doing that. No irrigation is needed. As I mentioned, you need irrigation for other technologies, Patients stay in the hospital. No irrigation is needed, this is an open platform that works with every mapping technology today on the market. The FULCRUM-VT pivotal trial, the IDE trial, was just presented the data at the HRS meeting this past April, recently, a few weeks ago. 209 patients across 20 sites. These 20 sites are 20 of 25 largest sites for VT ablation in North America. Key highlights. This was the first technology and study.
It was a rigorous study that focused on ischemic cardiomyopathy and non-ischemic cardiomyopathy. The outcomes demonstrated that both ischemic and non-ischemic were equivalent in their results at six months, all with an endocardial approach, which is a big deal. We had an 80% reduction in shock from patients prior to the study to after the study from their ICD. A 2.4% major adverse events compared to 10%-18% from RF and PFA ablation technologies that have been presented. A 72% in your AAD or your amiodarone use, which is toxic for patients but needs to be treated, so physicians try to get those patients off. Over a 50% reduction in the amount of lesions that were required for patients.
We had 12 lesions as an average in our 209 patients. There were studies that were presented with other technologies such as RF, PFA, and dual therapy that had upwards of 67- 69 lesions per patient. The endpoints for VT are very different than endpoints for AFib, and there has not been a standardized set of results from all studies across the board. The FULCRUM-VT study, as was presented at HRS, is the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies. 20 sites, FDA IDE, that is why this was a study rigor. This was not a registry, this was not early feasibility, it was an IDE study. The etiology, it was not just looking at ischemic cardiomyopathy and/or non-ischemic. It was looking at them both, and it was looking at them both through an endocardial approach.
The results spoke for themselves from the study that was presented, and the key moving forward into the future is making sure we are comparing apples to apples, not apples to oranges. There are many outcomes given from EFS studies and registry studies, single-site studies with fantastic physicians doing the procedures, which demonstrated higher safety issues, some higher complications, and some product failures. Compassionate use cases lets the entire world know, outside of a study, do physicians really want to use this technology? We have done over 13 compassionate use cases, and the physician reaches out to us when they have a failed technology that is approved or an off-label use, whether it is RF, PFA, dual energy technology, that they have had unsuccessful outcomes for their patients, that they have reached out to us and reached out to the FDA, and the FDA has to grant approval.
The picture that you see there is demonstrating these are geographic areas within the ventricle that you are not going to use many other technologies. We do everything all endocardial, but physicians are not as concerned with this type of a technology versus putting high voltage near the coronary arteries or going in the mid septal area or upper regions of the heart that are dangerous to try other technologies. I am excited to announce that we have our next-generation product that has already received IDE approval for pivotal trial for the second generation. Our science has been proven to be very effective with the ultra-low temperature ablation and liquid nitrogen, and now we are taking the catheter and making it even easier to use by taking a smaller catheter, a more bi-directional, more flexible catheter, makes easier access, and most importantly, it is going to be colder and faster.
What we can do in four minutes for an ablation time, we are going to be able to do in 30 seconds to a minute, and that is going to save significant time for our physicians. This has been demonstrated and presented at also the HRS meetings recently of the outcomes of this early data, and we are looking forward to starting our trial right away. At the end of the day, we look at the benefits of the ultra-low temperature ablation. It affects patients, providers, and physicians. Without going through it is safe for the patient, proven by clinical work.
From a provider standpoint, the fact that there's reimbursement and less patient stay, and a single product with a single access point makes a big difference for the physicians to make sure that they can keep the rooms moving and open up opportunities for those electrophysiologists that are not performing VT ablations because they refer them out because of that epicardial approach. By having an all endocardial approach, we're opening things up for our physicians all over the world, and they're not worried about some of the complications that occur with other technologies that was just presented, such as damage to the catheter, steam pops, and things like getting valve entrapment with other technologies. This fits under cardiac ablation reimbursement. Currently, physicians do this procedure, and there is full reimbursement.
We did receive our Breakthrough Designation in 2025, and we're working forward to see what happens with the add-on payment rules and regulations. We're wonderful, and we're excited about our regulatory timelines and major milestones. As I said, we've been able to accomplish everything in our path so far. Our PMA approval is expected on our first generation at the end of this year, which starts a U.S. limited launch immediately following. Our next generation, we expect our PMA approval at the end of next year. We will have our second-generation product approved already before any other technology's out there for commercial use. That's why we feel that we have a two- to three-year head start. Currently, we have $12.9 million in the bank as of the end of the first quarter that we just shared. We just completed a PIPE funding.
You can see as we talk about our Convert Warrants and PIPE Warrants. There's three sets of warrants and total base warrants, and we feel in a good position, and we're working forward to move on. We completed a PIPE in October. We have some great partners from leading healthcare investors. It's a three-tranche PIPE, and one of the key takeaways is full warrant exercise is already assumed in our fully diluted share count. We expected all these warrants to be exercised when we assumed our fully diluted share count. We want to share that with our investors. In summary, the two-year head start is real. There is no purpose-built VT catheter for a disease that takes more than 300,000 lives in the U.S. alone every single year, and it's an underserved market because of that, because of the complications.
This technology has shown through both our European data and now our U.S. data, the safety profile, the freedom from shock, the reduction in amiodarone, and the safety for the overall patients getting them out of hospitals quicker. We expect our FDA approval at the end of this year. We have our Breakthrough Device Designation, and we're really excited about our next generation starting to take all this great science and put it into a more usable product on top of what we already have, and then we already have established reimbursement. Thank you very much. Any questions?
About the data differentiation very clearly. Just to build on that, what do you think you can capture the market better than other technologies?
Well, I think it's the first truly purpose-built VT ablation technology. The fact that we can do this without compromise, as we say, meaning there's no irrigation, there's no nitroglycerin. There's a better safety profile that's been presented in the past. Physicians, based on their proof during those cases, what they've basically asked us to use this technology in outside areas where they haven't had success in the past, whether it's in the idiopathic, whether it's near the coronaries, whether it's mid septal. We've been able to demonstrate use cases everywhere in the ventricles without those side effects or without those compromises, so we feel very confident. The physician acceptance, they've made it crystal clear. The fact that it's all endocardial and the stability factor because the way the ultra-low temperature sticks to the tissue, there's nothing like it right now is what they've shared with us.
Right. Thank you.