Rick Sanghera, AtaCor Medical - Transforming Cardiac Rhythm Management | LSI Europe '22

Transcription

Rick Sanghera  0:08  

All right, hello, Rick Sanghera, the co founder and CEO of AtaCor Medical. With background I've been in cardiac device space plateau pacemakers and defibrillators for 25 or 26 years now, continuing in that space. Now I'll share a little bit about what we've been doing it at a core over the last few years, and what we've got coming in front of us. So AtaCor is kind of revolutionising bringing the next generation of cardiac device platform to, to the market. We're an extra vascular system. So instead of putting leads and wires inside the heart in the venous structure, we get them outside of the that environment into a connective tissue above the heart, you can see a delivery tool here that's just adjacent to the sternum through a rib space. With that we're doing temporary pacing leads, we're doing defibrillation leads, and we're going to be expanding into longer term use there about but it really does create an entire platform for as I said, the next generation of cardiac devices. First, we'll talk about the fibrillation. It's a large market, it's existed for a long time. But again, what we've been trying to do is make these devices less invasive for patients easier to put in and get them outside of the cardiac environment where the hearts beating 100,000 times a day, 35 million times a year. Eventually physics wins. When we put something in the hardest, it's got to be subjected to all of that kind of flex fatigue. And so we can do is put something just through a rib space sits in the connective tissue above the heart and connects into an existing ICD an implantable defibrillator that's already on the market. So we take existing devices that are meant to be attached to leads inside the heart and effectively convert them and make an extra vascular ICD system with them. So here you can see an image the blue device is that extra master ICD, the red device here in pictorial and showing our our leads. Here, I want to walk you through an animation of how we put this device in. So using anatomical structures of the heart so we can feel the ribcage around their their sternum feel for that rib space just above this iPhone. And that's really where we're going to target our insertion. Here you can see our lead with a couple of different electrodes on it that allows us to sense the cardiac rhythms, and then coils to allow us to deliver energy as well. So here, looking at the anatomy, again, it's that rib space just adjacent to the sternum at the left sternal margin, we've got a delivery tool that facilitates entry into that target tissue. And then the lead is deployed in that kind of the space above the pericardium. So we do not invade the heart at all with that lead and we can then tunnel it towards a lateral device pocket that's very familiar to physicians now. And with that system again, since the cardiac signals determine when we need to deliver life saving shock and deliver that shock across the chest. And here you can see the tunneling procedure. And then finally, the device implant as well. So all of this is meant to free the veins free the heart from all the stuff from all the materials being inside. Here's an image of a lead. Today we've been doing a lot of clinical work. As you can see here, we've done our first acute study, we've done our second acute study to study defibrillation energy sensing capabilities, implant procedures, already actually completed our first chronics evaluation. To date, we've done all about 36 patients already. So we can absolutely tell you that there's plenty of energy in the standard ICD is to be able to connect to our lead and deliver life saving shocks. We've done that already. And we're well on our way here. So our first kind of summarize, acute data is the 94% lead deployment success with our Gen one system that has taken about 13 minutes to put the lead in and that includes the incision. So in the incision at the sternal margin, getting down to the tissue deploying the lead, removing the tool for finally position. We've been inducing VF, so we induced ventricular fibrillation in the operating room, sit back and let the devices recognize that device deliver the energy through our lead. And every time we've done that with four different manufacturers now, that signal of sense automatically triggers a shock delivery. And there you can see our mean energies at 17.1 jewels. Those in the space will recognize well within the capabilities of existing architecture. Most devices are about 40 jewel systems now, so plenty of headroom for us there. We've just completed now our chronic data that's not on the screen here yet, we'll be working towards publication of that data. So as we're going through the CDC milestones for different elation, you can see, we'll be using funds as we're raising now to, to work towards a pilot study that'll start at the beginning of 2024. We're also a pacing company. As a startup, we've got two different platforms going, and today's pacemakers as we look at them and think about temporary pacemakers, which are used in conjunction with other procedures are in the emergency room in the hospital, few 100,000 cases a year in the US alone, with a high complication rate. So certainly room for improvement in our system. Again, it's implanted at that sternal margin through simple incision, we can deliver the lead without fluoroscopy. So we can really reduce the complication of therapy delivery in the emergency department, as well as provide the high rate pacing and all the things that are needed with traditional, say, Tabby procedures. That creates a lot of value creation immediately, especially for in the operating room, or the emergency departments. Emergency department, we can shorten the time to deliver the important care that's needed for patients that are symptomatic and bradycardic when they come in, and without having to activate the cath lab after hours, saves the several $1,000 in deployment costs for the hospital. Switching over to Tabby procedures or other procedures that require temporary pacing, a big proposition there, if we can allow us to ambulate patients after the procedure, get the patients out of the ICU beds as well. So thinking about all of our milestones here, on top, we've got temporary pacing now we've talked about defibrillation to date. Now what we'll be working towards a final research studies just completing now, we'll get to a pivotal study for this product next year. And that led lead to a 510 K submission because a temporary patient is class two. So think about the total financing. To date, we've been blessed to be able to fundraise throughout the last several years through COVID as well, we're actually 43 million close to date. For both of these product lines. These are large markets, lots of addressable market for both sides, you can see some great partners along the way we've had a couple different corporate investors as well. And what we're looking to raise now with the milestones identified here again for Evi CD, or to fibrillation is getting to a pilot study in 2024, with temporary pacing leading all the way through our pivotal study and getting to FDA and CE mark clearance looking to raise $35 million, now to take us through that, that horizon. And so as we think about all the different platforms going forward, again, Evi CD is a large market, it's established now and we're facilitating a less invasive way for that there, therapy to be delivered. As we think about pacing. Temporary pacing used in hospitals is an important part of our kind of platform and our strategy to start there, from a regulatory point of view, prove the safety nets and efficacy of the of the pacing, and then move towards bridge pacing and permanent pacing, bridge pacing being a 30 day device where we can just adhere that device to the skin and provide that kind of bridge to therapy, certainly after Tabby procedures where now we're kind of immediately jumping into putting a permanent pacemaker in where you know, the data suggesting that thereafter we probably don't need that. And so we're kind of building towards a platform where we can kind of bridge towards a permanent device decision in a month. So with that, I'll end it there and happy to take questions after that.