Nick Talamantes 0:00
Amos. Thank you so much for joining us here at LSI Europe. Thank you tell me a little bit about CardiaCare
Amos Ziv 0:05
Right. So CardiaCare is, we're both therapeutic. So basically, this is a device that I have right here on my arm. It's a device that actually delivers nerve stimulation to the wrist and it targets the vagus nerve, which is here on the neck. And basically what we're doing is we're reducing overdrive of the nervous system that contributes to the development of AF and also for the progression of AF. So it's unique, the fact that it's a wearable that actually treats people as not just another monitor.
Nick Talamantes 0:37
So as a wearable therapeutic is there, what are the diagnostic capabilities like of the device,
Amos Ziv 0:42
right, so basically, it is a closed loop device, we have a single lead ECG, where we actually track the arrhythmia. And we have continuous heart rate sensors. So the idea is that we can track or identify changes in heart rate, validate them with an ECG and treat them in order to prevent the upcoming event.
Nick Talamantes 1:03
Tell me a bit about the unmet need and treating atrial fibrillation today. Yeah,
Amos Ziv 1:07
AF is the most common cardiac arrhythmia, or sustained cardiac arrhythmia, it affects around 30 million people worldwide, in the US expected to be about 20 million by 2015. And, in fact, one in every four people over the age of 40 in the future will get a AF so, so there's a huge unmet need also because current therapies are lacking complete efficacy, I want to say so it's a big problem. It's become it's it's defined as a cardiovascular epidemic.
Nick Talamantes 1:43
Tell me a bit about the current standard of care for atrial fibrillation and how you guys compare? Sure.
Amos Ziv 1:49
So current standard of care involves either drug therapy, which is two types of medications. It's the anti arrhythmic drugs which have a lot of side effects and normally stopped working after a while, so you need to increase dosages and change doses. And those the blood thinners which prevent, you know, the risk of stroke. It's important to say that AF basically as a condition when you have it is not a life threatening condition at at that moment, however, it increases the risk of stroke due to blood clots and heart failure and a heart attack. So, so current standard of care, one is medication second is called cardioversion, which is basically a procedure which we actually zap the heart with high voltage electricity to bring her back to normal rhythm. Unfortunately, that doesn't last and we the recurrence rates are very high, almost 30% within a month, 80% within a year. And on the recent technology, the biggest advancements are the ablation procedures, where they actually go in with a catheter to try to either burn or freeze, the area suspected of creating the arrhythmia. Success rates are high in the first year, almost 80 to 90%. But as AF as a progressive disorder, the long term success rates are low, so almost 50% failure rates at five years with ablation.
Nick Talamantes 3:13
So you mentioned about 30 million people will have AF soon
Amos Ziv 3:18
Oh, 30 million people have a FTD worldwide. And the US is going to reach these numbers in 10 to 15 years,
Nick Talamantes 3:25
what is the market opportunity look like then or device like yours today?
Amos Ziv 3:29
It's a $7.4 billion market. And it's you know, it's it's it's increasing? Unfortunately, the age of getting AF is reducing all the time. It used to be an elderly population disorder. But we're seeing young people today getting AF for a variety of different reasons. By the way, COVID has actually increased the incidence of AF because the immune response triggers an autonomic nervous system response, which triggers a AF so, so. So we're seeing an increase in I have a lot of cardiovascular conditions with COVID. But I have quite quite a lot too.
Nick Talamantes 4:08
That's really interesting. So how early in the sort of care management process for an atrial fibrillation patient, would you be able to receive this technology,
Amos Ziv 4:19
right, so we're targeting to two populations. The first population is the early it's called paroxysmal AF population. So as AF is a progressive disorder, it starts with these bouts with these attacks that you have which are called paroxysmal AF, which are getting the population early population, this population where you have these patients that have recently been diagnosed that say over in the in the past year, and the idea is if we treat them early, we are able to prevent the progression of the disease from these stages which are defined as paroxysmal initially persistent and then chronic AF. So We're targeting the elderly population, that's around a million people, new people each year are in the US. Another population is the patients that undergo an ablation procedure. A part of the failure of the ablation has to do with the fact that are these are called ectopic are these areas in the heart which create the arrhythmias. And they create these precursors arrhythmia, which trigger the AF. Now what we're doing part of what we're doing is we're actually obliterating these PAC's, they're called these premature beats. So there's also a lot of interest from the industry to show if we can actually help as adjuvant therapy to ablation, right after an ablation, to use our device in order to increase success rates. With ablation, and keep in mind, this is also a monitor, so looking at these patients right after ablation to see what's going on with them. So these are the two major populations.
Nick Talamantes 5:54
That's really interesting. What does the stimulation actually feel like when you receive it?
Amos Ziv 5:58
Oh, yeah, it's it's, it's not unpleasant at all. It's like a mild tingling, which you feel around here, going up towards the rest a little bit and towards the palm. Basically, once you target once, once you feel that you've basically targeted the nerve, we're measuring a bunch of parameters, like electrical parameters to make sure that we're on the right target, and the placement of the devices is correct. But it's like kind of like my mild tingling, electrical sensation,
Nick Talamantes 6:26
and is the response to the administration of stimuli instantaneous is immediately correcting the irregular heartbeat.
Amos Ziv 6:34
So our sessions are not very long. They go from 25 to 45 minutes, when we connected patients to monitor to heart rate monitors, hospital monitors, we've been one of the studies, you can see that within five to seven minutes, you've got to see you're seeing these PHCS or these ectopic sites beginning to quiet down so so it's so it's fast.
Nick Talamantes 6:56
That is incredible. Right? What stage are you guys at right now with your technology?
Amos Ziv 7:00
Right, so when clinical stage we finished, finished our success successfully finished our first in human clinical trial when we had 80 AF patients that were actually received our therapy from the ER so we recruited patients from the ER, one of the major hospitals in Israel Sheba Medical Center, patients that arrived to the ER with a February cruise that study that got our device for eight weeks of therapy, therapy and monitoring. And that was the first human next step is our longest study, bigger study. So 26 weeks of follow ups almost six months with because this is what the FDA is looking for.
Nick Talamantes 7:39
So you're working with the FDA, does that mean you're going to the US market first?
Amos Ziv 7:43
Yeah, we're targeting the US market. First, we're going under what's called the de novo 510 K path where we actually need a pivital that is going to be in the US right around 200 patients and clinical phase.
Nick Talamantes 7:57
What is the long term outlook look like for cardiac care? Is it acquisition? Are you going to adapt the technology for other indications?
Amos Ziv 8:07
Well, we hear that the most probable scenario is an acquisition in May. I would say that, since we're doing vagal nerve stimulation, we have the potential to use this for additional indications. So I think we'll need to consider as these as the offer comes.
Nick Talamantes 8:27
Is there anything in the pipeline?
Amos Ziv 8:29
In terms of another indication? Yeah, there is actually there is. It's more consumer, though. It's like us, it's actually sports recovery. Okay, yeah.
Unknown Speaker 8:38
Could you talk a little bit about it?
Amos Ziv 8:40
I can, I can live it. So what happens often. No, there's a lot of these apps now, a lot of the washes actually, that tell you if you've recovered from your sports, a few well recovered or not. And some of that major aspect of that has to do with basically the autonomic state of the nervous system, what we're able to do is as recorrect, or corrected much, much faster. So if you're entered into sports in in sub optimal condition, and you recovering very slow, because something's gonna like stuck in overdrive, we can bring it right back down. But that said, I mean, that's our you know, it's fascinating. It's, yeah, it's great. It's in the future. Again, coming back to AF it's a huge problem. We want we love it, we know we can treat them. We know we get excellent results. There are so going to do a AF first right away.
Nick Talamantes 9:39
I love companies that have sort of a long term vision of the future, you know, not just planning for the exit, but planning on where you could take the technology next.
Amos Ziv 9:46
Yeah. Even in the cardiovascular space. There's other indications that actually can benefit from reducing this over sympathetic drive or heart failure, post MI recovery and of course how Blood Pressure all suffer. All the excess sympathetic drive contributes these conditions as well. So there's, you know, there's a lot of possibilities, but gotta remember focus, though.
Nick Talamantes 10:11
Yeah, absolutely. Well, there's a lot of opportunity and all of those potential indications, they're massive problems that society is dealing with. So it'll be interesting to follow along how your company is developing. Focusing more on the conference, what brings you to LSI Europe?
Amos Ziv 10:28
Right. So at OSI is, first, I want to say it's one of the best investor conferences I've been to. And we're part of the Medtech Innovator cohort. So we were actually connected to LSI, through the NTI, 220, cohort. You know, as a company, and we're always fundraising. So it was a good opportunity to meet a lot of investors here, high quality investors, I want to say that, so networking, networking, with that respect, also met with some providers regarding our clinical program. So finding it great,
Nick Talamantes 11:03
why don't you tell me a little bit about the evolution of wearables where they're at today? And where you see them going?
Amos Ziv 11:09
Well, that's a great question. Thanks for asking that. So we've always said that wearables have this stay on stage another approach that started as consumer devices, they are moving to medical grade monitoring devices, like the Apple Watches ECG and the Fitbit and the Samsung ECG. But we always believe that the next stage of the of this evolution is going to be therapeutic. So if you asked me what you're going to see in the next 10 years, allow these devices that actually treat patients. Okay. Now, this is not, this is old news. We have insulin pumps, and we have cardiac pacemakers, but the external non invasive stuff is coming out.
Nick Talamantes 11:49
That's exciting. Well, Amos thank you so much for this interview. It's great talking to you. Thank you