Ken Coffey, AtriAN Medical - Resolution of Atrial Fibrillation | LSI Europe '22

Transcription

Ken Coffey  0:05  

So I'm pretty excited to share with you we're taking a much different approach to the standard approaches for atrial fibrillation, but most of us know a relative or have a friend that has atrial fibrillation. So we'll just briefly discuss this, and what the problems might be. So really, what happens is that when you get a fibrillation, your heart starts to quiver, it starts to formulate, and it doesn't eject the blood. And when that happens, you know, stale blood will start to clot and that it can go to your brain and the really, the risk of stroke is the biggest thing. But there's also contributions to heart failure. So the what is standard today really fails patients about half the time. So we're gonna go through the treatments, if you have atrial fibrillation, we'll walk through exactly what the treatments are. So if I had 30 minutes, I'd take you through a journey of our company, our milestones, and things like that. But we're going to cut it kind of briefly and just speak specifically to the investors right now. So basically, it's a giant market, you know, in excess of billions of market, irises about a 2 billion market space, there's an unmet need. Again, there's really no great solution for atrial fibrillation. It what we have is a disruptive technology of using that pulsed field technology. But we're taking a different approach and a different target. And we've got 36 patients treated. So I'm very excited to share that with you, and to share our success of our team. Again, I could take you through the detail of the the market size, but really ultimately comes down to the fact that this is a huge market. And it's growing for really two reasons there's a greater awareness of atrial fibrillation, I've my Apple watch it tell me if I have it or not. physicians know about it, they're targeting it more, but also we're getting older. So this, this market is growing about 14%. So the space is getting bigger and bigger as we go forward. So the first line of treatment, if you have AFib feels like a fish in your heart if you have symptoms. So you sort of go to the a&e or you go to the emergency room, and they'll give you drugs and those drugs work about, I'd say about 70% of time they fail, so they work about 30% of the time. The key here is that if you get those drugs, you still feel really bad, some slows things down, you're lethargic, and those drugs impact every organ in your body. And specifically, the most successful one amiodarone will start to take its effect on your lungs. So the long term prognosis for drugs is not good. If you you want to proceed into what they call this ablation, which Avi and then David's going to speak about. Basically, they're going to go inside your heart, and that's key inside your heart. And they're going to create these scars using heat or laser, or cold around your pulmonary veins because a lot of the entry for the signals that are coming from outside your heart travel through these sort of like motorways or highways, so they intentionally scar your heart. And the problem with that is that after a while after about 12 months, 30% of the people that fails, they have to have a second ablation. After about three years, about half those people will have another ablation. And those procedures get more aggressive. So they start to take out more tissue. So they basically go in and intentionally burn or freeze healthy heart tissues. So what that that is the standard of care today. And again, what we're doing is taking a completely different approach. So this is what this called endocardial. Inside the heart approach. We're taking an epicardial approach. We're going outside. So what you see here is a surgical theater that we treated. This is actually in Homolka in Prague, one of the best electrophysiology sites in the world. And you see our team there. There's John's all bound up. I think he's watching this online. You're looking good, John. And you'll see Martin Van CO from Mayo Clinic is there along with Dr. Scelsi. And Peter nosal and the fact ready, we're overseeing this as well. And our system is a giant generator that delivers these very, very intense high voltage pulses, that we have these specialized catheters to deliver these, this treatment on the outside of the heart. Now our first studies are open chest so we can have full visualization to targets and that would be the next step. So the high resolution conversation here is we're actually interrupting the autonomic so we're going for cardio neuro ablation, and that's quite a mouthful, but you'll realize it that's being done for other sort of neuromodulation or newer ablation, for things like blood pressure, Parkinson's, etc. So that's sort of the new field that we're addressing here. And again, we're also taking a different approach. We're not going inside the heart, we're going outside the heart. So we do just a slip. We just a small scalpel, we slipped the catheter under the breastbone, and then target these five specific sites in the heart. If I go backwards here, you can kind of look at these sites. This is what connects your brain into your heart. And those are the actual sites that we're we're targeting and sort of a blading. And sort of figuring these hyperactive cells down a notch, almost like, you know, your oversteering or something in a car. So we sort of a blade that and it sort of calms the heart down. And it should be permanent. So a lot of competitive feeding people in this space, obviously, ablations are huge. And you'll see most of them are trying to move to this pulse fields, because it is, as I say, higher safety profile. But the outcomes seem to be about the same. So it's the definition of, you know, what if you try to do something over and over and over again, and you're expecting a different result. And that's exactly what's happening from this endocardial approach. We think that the endocardial plus the epicardial, as an additive or common a procedure, which can be done in different days, is really going to move the needle, because this was invented ablations were invented in Bordeaux about 20 years ago. And the last decade, there really hasn't been any significant progress on the outcomes, we're going to change that. So again, we've treated 24 patients and two centers in Prague and Tbilisi, and that was safety and efficacy trial. Again, there's our mayo team along with the Prague team. And then we just recently closed out 12 patients enrollment and into Blasi in June. So now we're monitoring the outcomes for their AFib recurrence. Three months should be coming in quickly, the real powerful data is going to come in at six months and of course, 12 months. So it's going to take about 30 million to get through FDA approvals. We've got a nice plan, we're detailing that out. As we speak, again, robust IP portfolio. The technology came from Mayo Clinic from Sam Astor have atham, arguably one of the top electrophysiologist in the world. So that IP was constructed very, very well. And we've added to that incense. So the question is really why now why is this important? Well, pulsed field is now becoming really accepted in the cardiac space. As we know from the fair pulses, Medtronic students studies, these gentlemen here are going to tell you about their technologies as well. And it was originally developed for oncology and clinical application. Now, the only targets that are really remaining that really are undiscovered, really untapped with the epicardial targets. So again, we're going after the origin of the problem. So the first principles, we would suggest that if you really want to stop something, you go at the very root cause of that. And so previous trials used RF energy, they actually tried these epicardial targets. But the because of the burning, they couldn't actually get all these targets that were able to do. In fact, we're the only company that's ever globally ablated all of these sites. And so there's, again, there's really been no significant progress in the current treatments. We got a remarkable team, but let me just let me talk a little bit about a few characters on here. I know we don't have a lot of time. First of all, our team that has been extraordinary retreated 36 patients in the face of COVID. With a lot of COVID hotels we we stayed at in crossing borders, it was a real challenge, but we got the work done. So our team, especially Barry and John there, we're just you know, fantastic at this. We've added Mark Carlson I want to that's been done very recently Mark Carlson. He was the CMO, the Chief Medical Officer for St. Jude and then of course Abbott. So we just brought him on as a deck director, and then John Hunt also, we just elevated him the chair position on our board and he's had three significant exits in the AFib space. The most recent was Bharti so I think that's that's knocking around a billion exit for John. And again, I just want to thank you for your time below. I'd love to talk to you at any time, and hello to my family and my dad. Great thanks