Avi Fischer, ElectroPhysiology Frontiers - Treating Atrial Fibrillation | LSI Europe '22

Transcription

Avi Fischer  0:04  

Thanks, Doug. So I'm Avi Fischer, I joined ElectroPhysiology Frontiers about a year ago, a little over a year ago. I'm an electrophysiologist by training, so I guess the company's fitting. And after spending about a decade in clinical medicine, I spent another decade in medical industry and left Abbott Laboratories where I held the role of chief medical officer up until last year when I joined ElectroPhysiology Frontiers. And it's really exciting to be taking on this, this role and building out this company. It's an exciting time in this space. I also think it's appropriate and I'm glad to be here in the month of September, talking about atrial fibrillation, talking about what we're developing, because September is AFib Awareness Month. And so again, it's very fitting to be here pitching, hopefully a very novel solution to some of the challenges associated with with atrial fibrillation. So for those who are not aware, atrial fibrillation is the most commonly arrhythmia seen in practice, and experienced in the world with approximately 50 million people with atrial fibrillation, and the rates of atrial fibrillation are increasing in prevalence at alarming rates. The number one risk factor for the development of atrial fibrillation is age. And so people are living longer, it's more likely that they're going to get atrial fibrillation. And in the United States, for example, with people over the age of 65, or 70, almost 10% of the population has afib. And this leads to lots of associated medical conditions like stroke, like heart failure, all frequent causes of hospitalization and the need to seek medical care. And this is a real epidemic problem that over the years is going to explode. And you can see, the estimates are that in 2050, Europe will have the most concentrated number of patients with afib anywhere in the world. The markets a very robust market, already many billions of dollars are spent treating AFib through ablation, millions of catheters are used somewhere on the order of 600,000 af ablations are taking place every year. And the the rate of penetration, unfortunately, of ablation therapies into the Available Market is extremely low due to what I'm going to explain now some of the complexities some of the challenges. And some of the issues associated with contemporary therapies and available therapies for treating patients with atrial fibrillation, the market is good, there's growth. And due to some of these complexities, you can see bullet three here, there's there's this notion of single shot devices, which are really taking the the forefront of the marketplace. And as many people know that the the m&a landscape is very attractive, very aggressive. And so great opportunity for ROI from an investment perspective, and of course, with the patient front and center, great opportunity to really have an impact on on patients globally. So I won't spend a ton of time here, but this is sort of what's available now. And if you look at the top image, the don't know how to do this, I guess I can't point. But if you look at the top image, this is sort of the gold standard approach what we call focal point ablation. And the tip of the catheter that you can see there is about 3.5 millimeters in size, and it delivers very discreet focal lesions that need to encircle that pulmonary vein. And those lesions that are delivered have to be delivered so that they're touching one another. This is great, because it's a it's a it's an efficient, well known, well used approach to treating arrhythmias. However, it's very cumbersome, the learning curve is long. And it's a very complex procedure requiring lots of staff lots of infrastructure in the room to perform the procedure. As a result of some of these challenges. There has been a really nice solution that has come to come to market called the cryoballoon. And this uses another form of thermal energy as the single shot approach where the balloon is placed in the vein, and then the entire vein can be a bladed without the need for a lot of manipulation of the catheter. During the ablation procedure, it's thought to be safer, it's definitely quicker, it requires less skill. And the aim is to make this technology and make this procedure more available to a larger number of physicians, but because of the nature of the way the ablation is delivered, this cryoballoon the single shot approach is all or none. It's either on or off any thermal approach ablates indiscriminately. And therefore there are some very significant complications and issues associated even with this approach. And so the aim is to continue to simplify, it's always easy to make things more complex. Our aim is to simplify the approach to broaden the access to this procedure to physicians, to allow for all of us who are performing these procedures to do it in the same way and deliver the same type of lesion sets. We want to do it quickly, we want to do it safely. And we want to democratize the ability to perform this procedure, which again, will hopefully lead to greater penetration, greater inflow of patients to receive this valuable therapy, ultimately, helping patients families and global healthcare economics. This is up there just to sort of show you what the competition is. And I know some of my colleagues will be following up with similar probably slides and presentation. So I'm doing some of the groundwork now, building the the story for afib. But you can see that there's been a lot of effort on balloons, there's been a lot of effort balloons with multiple electrodes. And I put this up here, so that you can get a sense of what this looks like, because soon I'm going to show you what our catheter looks like. But before I do that, in addition to the exciting opportunities with catheter design, there's a lot of excitement about a new energy form, at least in electrophysiology, for treating atrial fibrillation, and this is called Pulse field ablation, or electroporation. And as opposed to any thermal ablation approach, this is very tissue specific, and the aim is to deliver very rapid in microseconds and sometimes even nanoseconds. Very high voltage electrical fields, which ultimately, destabilize cell membranes caused the formation of nanopores leading to a slow programmed cell death. Again, the key here is it's tissue specific. So some of the collateral damage seen, and collateral risk associated with thermal energy ablation does not exist here. And a lot of the excitement is over the safety profile, rather than upping the ante on recurrence rates and definitive elimination of atrial fibrillation. One of the challenges associated with pulsed field ablation is that it's a complex recipe, which needs to really be optimized to the specific electrodes that are delivering the PFA because it's an electric field that's being developed to, to ablate the tissue. And that's where the promise and excitement is existing around the safety profile and the efficiency of the rapid ablation. So this is our catheter. And as we aim to simplify things, we were simplifying things by making a complex catheter. And this is an over the wire catheter. So arguably, this can be done anatomically, without the need for some of these ancillary mapping technologies that can be used if needed. And we've embedded electrodes on the different elements of the distal end of the catheter to enable that, but this can be done as a purely anatomic approach. And if you look at the middle image, which is the human heart a human cadaver, you can see that the guide wire is placed, the catheter is tracked very simply over the guide wire. The anchoring mechanism, which is on the distal part of the catheter can expand and take a number of sizes. And what this does is it mechanically stabilizes the catheter within the beating heart so that the two are moving together as opposed to a beating heart and a catheter that's moving separately, and the operator is trying to maintain contact. This is a mechanical stabilization, which then allows for and I apologize that CLA is not spelled out that stands for circumferential linear array. So there are four linear electrodes that are mounted on a frame and they can be placed and you can see very nicely on the right side of the screen that cartoon how it sits very nicely at the orifice the Ostium of the pulmonary vein. And because the shaft of the catheter is is central, it really lines up nicely with the anchor. And it allows for a circumferential single shot ablation to be delivered with again, changing sizes of both the anchor and the CLA to to accommodate individual patient anatomy. And then one last thing I mentioned as opposed to occlusive balloons, which you saw some of them on the previous slide, both the anchor and the CLA are open so the blood flow that drains blood from the pulmonary veins in the lungs into the heart can proceed without impediment. I don't know if the clock is right, it's blinking. I gotta wrap it up. Okay, anyway, we have one of our key assets is our IP portfolio. We have 59 patents already submitted 50 or 51, granted a key asset for us protecting both the anchor and the CLA. Unfortunate I'm not going to get to all of this, but I'll simplify this. This is what we did up until now you can see today, we've done a lot of work and a lot of this happened during COVID, prototyping design, PFA work. And we're now in possession of a gen one full system, customized PFA catheter with a very well established electroporation company that has over two decades of experience in the field that has customized a PFA generator for our electrode design. And where are things going in the future? Well, so I have manufacturing up there, fingers crossed supply chain has not been anybody's friend. And so but we're getting we're beginning the manufacturing, we're beginning optimization and all of the preclinical testing required by regulators to perform our first in human study, which will occur in 2023. And we're preparing for regulatory required studies both in the EU and FDA to ultimately receive regulatory approval and commercialization of promises is, I think, my last slide. Management Team Often people talk about decades of experience. We have a century of experience in cardiac ablation and cardiac electrophysiology, between the five people on the screen.  Marwan on the right recently joined us as Chief Technology Officer, the cryoballoon that I showed you earlier, he developed and led the r&d team for that technology that was acquired by Medtronic for somewhere between four and $500 million. I'll skip this. So from a financial perspective, again, we've got a runway, our next big milestone is first in human, we're privately funded. For the time being, what I'm doing is preparing and identifying partners for next stages as we begin to scale up as we begin to prepare for clinical studies that are going to be large studies, multinational Global Studies, beginning to search for those partners, manufacturing as we begin to grow the company, again, planting the seed for fundraising that will take place in the future, not today. With that, I thank you for your attention, and hope everybody enjoys the rest of the event here.