Amos Ziv, CardiaCare - Neuromodulation Device to Treat Atrial Fibrillation | LSI USA '24

Amos Ziv  0:02  
Thanks for coming and thanks for the opportunity to share with you what career is doing. So my name is almost Ziv, I'm from Israel and I'm the founder and chief scientific officer of CardiaCare. It's the world's first wearable that treats patients I'll say it again, it actually treats patients with non invasive nerve stimulation on your wrist to reduce arrhythmias. More specifically, cardiac arrhythmias, atrial fibrillation, which is the world's most common cardiac arrhythmia. So age of ablation is, as I said, the most once common cardiac arrhythmia, affects more than 35 million people worldwide, projected to be 70 million around 2050, with about a million new patients each year. It's a progressive disorder that actually starts with initial bouts that come and go, but then progress into these permanent episodes of fib, which you need to get at the hospital and get cardioverter which is an electrical shock to the chest. And then if that doesn't work, they go into a procedure called ablation and often ends up in what's called persistent or permanent atrial fibrillation. It's a disease that actually increases the risk of stroke and heart failure and overall death. And the economic burden on the system is enormous, amounting to about $10 billion a year. So, current standard of care involves medications, both anti arrhythmic drugs and blood thinning drugs to prevent stroke. The medications work initially, they stopped working over time, and they have a lot of side effects. Next, we move into the procedure. First procedures are cardioversion which I just mentioned, success rates for cardio versions are low. So within one year 80% of patients have relapses of AF episodes, and then ablation, which is the gold standard, and blockbuster procedure for this, for this condition, have excellent success rates in the first year, let's say 70 to 80%. Some physicians have 90%. But overall over time, after five years, the overall success rate success rates and failure rates actually are close to 50% of ablation therapy. And the patients suffer from symptoms or debilitating side debilitating symptoms like palpitations, chest pain, anxiety, fatigue, often lightheadedness, and sometimes fainting. So this presents an opportunity this presents the opportunity for cardiac care to come in as an adjuvant to standard of care. Again, we're not here to replace standard of care, we're here to add, since standard of care is lacking optimal efficacy. So imagine a wearable that actually treats patients at home and non invasively. And I'll explain in a minute how we do that wearable that will decrease hospitalizations, decrease procedures, and, over time, improve patient's quality of life, which is the most important thing Well, this is why we're all here. So this is exactly what we've done. And cardiac year is the world's first non invasive drug free neuromodulation nerve stimulation wearable that actually treat these patients at home, but also monitors them, we deploy optical sensors and ECG sensors here on the wrist. And in a closed loop manner. We actually analyze AF precursors of upcoming episodes, we alert the system, the patient and the physician. And we treat these patients both to prevent upcoming events and also prophylactically for preventing episodes. It's the actually it's the only management tool that actually as a complete management tool that actually treats these patients. So a lot of companies actually monitor patients, but no one's delivering therapy. So how does this work? We're deploying someone with something which is called Vagus Nerve Stimulation. The vagus nerve is a big nerve that actually controls the autonomic nervous system, which controls heart rate and rhythm. Now vagal nerve stimulation has been shown the ability to reduce arrhythmias and specifically AF and some invasive procedures and some invasive technologies and some non invasive. So ear stimulation, which has a branch of the vagus nerve has been shown to reduce fib, direct vagal nerve external stimulation at the neck, we're deploying a novel approach from the wrist, we're targeting a nerve, which is called the mediate nerve, which is very close to the surface right here. And you can reach that nerve with these electrodes that we have on the device. So we've been able to show that in both animal models and human studies, which I'll share with you in a minute. And again, the whole idea is to control the autonomic nervous system. So it doesn't go into these hyperdrive situations which are called excess sympathetic or excess parasympathetic, which are triggers of atrial fibrillation. So we monitor patients, we affect the brain in a specific area called the NTS medulla in the medulla, and then we regulate cardiovascular cardiovascular function to reduce atrial fibrillation burden incidence We've completed successfully a first in human study. This was a 10 patient study that in Israel in a medical center called Sheba. These were patients that actually arrived to the ER with a fair bit, they will cardio verted back to normal rhythm, and then received our device for eight weeks of home care, both monitoring and therapy, we've been able to show and this initial small cohort study again, this was designed just as a usability feasibility and safety study with even in a small cohort of 10 patients, we've been able to show very interesting efficacy, so reduction in AF recurrence rates over eight weeks of almost 50% and enticingly, also acute reduction and precursors of AF, which are called pa C's or premature atrial beats, which are, which precede if, again, almost 60%, we're seeing both acute reductions within the neuromodulation session, meaning when a patient is connected to a hospital monitor, you see these pieces are showing the ECGs in a minute, as you treat them within 25 minutes, you see the reductions of these precursors, which then, as I said, we reduce the chance of getting AF, from seeing both acute responses, which you can see on the left hand side. These are numbers of premature beats before and right after treatments with our measure measured with otherwise, our device and then verified with a 24 hour golden gold standard holter monitor at the beginning of the study versus the end of the study. So this was a small study, I'll tell you about the studies that we have going on these days. overall safety profile was excellent. None of these patients had severe adverse events, none of them came back to the hospital over the eight week period. And in terms of compliance, the patient's lover device, we're getting 80 to 90 more than 95% compliance on both monitoring aspects and treatment efficacy. And again, this is real world population, average age here was 64 years old. So we deploy two types of treatments. A concern on the left hand side on the bullets, a predetermined treatment dose, you'll get, let's say three neuromodulation sessions a week, by the way, we don't continue continuously stimulate these are short treatments of around 20 minutes. And in addition, whenever a system picks up these precursors of AF will give you additional acute treatments. So this is an example of a case study, patient was 6% age information burden, which was measured by two weeks zero patch, it's an ECG patch that you were for two weeks 6% may not sound a lot, but it is it's like an average of an hour and a half of fib day, which is a lot. So we track the patient's ECG. As you can see the report this is report from our from our device, physicians love it the signals excellent you can see the P wave, which is what you're looking for, in the average cure X beat, we analyze the ECGs on our data, cloud data with our AI algorithms to detect AF or precursors of a f we alert either the physician and the studies, we're alerting the physicians with a text message and an email where they get the report. And the future is gonna be done with a call center. And we already run a pilot for that. And then we deliver these therapeutic treatments overall. In this case, you can see reduction of 50% for this patient, again down to 3%. And this was only done in eight weeks, we believe that longer follow up, which is what we're doing these studies will see even better efficacy more than 3% reduction 50% reduction. This is what it looks like on an ECG. On the left hand side you can see an ECG with these blue circles. That's those premature atrial beats. You can see on the right hand side 20 minutes afterwards is a completely gone to this patient you can see 100% reduction, we don't always get 100% We get anything from 50 50% to 100%. But in this case, you can see 100 reductions in these precursors of AF. We have grandparents on the engineering aspects, the hardware aspects of the device, We have granted patents on methods for nerve stimulation. And we have pending provisionals on the algorithm and numeration algorithms and procedural outcomes and additional provisionals on some additional stuff indications currently are in terms of reimbursement and go to market. We're exploring two possible avenues already have been shown for non evasive neurostimulation. The first one is called DME or durable medical path, with device sales over a period of 13 months, amounting almost to $3,800. Again, there's those, there's comparables for this. And also we will be utilizing existing CPT codes of remote patient monitoring or even more remote patient therapeutic codes which actually allow access to the physician to look at results of therapy. And another option that we're looking at as the pharmacy benefit. pharmacy benefit allows a rental model and not a sales model, where actually these patients will rent the device. This goes anywhere from $125 a month. Again, there are comparables that have shown this in a couple of couple of companies.

We've completed our first in human clinical study. We're halfway through the study in Israel and also soon to commence here in the US at Mass General at the early paroxysmal. population. And we've recently received just two weeks ago approval from FDA to run an additional study on additional postprocedural stealth indication which I can elaborate a lot on. And couriers are so far has raised $5.1 million out of them 4.2 And dilutive out of the 900 in grants, and also are my service licensing agreements. Last round was in July 2.1 million with a post money valuation of 12 million. And it will be kicking off in a round two will be our targeting to complete again, a round of around 10 50 million around December this year, which would take us all the way up to FDA clearance about first indication on q1 26th. We have a very strong team both from the regulators, both from the clinical perspective Kol leading Kol and the clinical worlds. Also industry experts multiple axes behind this slide more than seven. So again, a very strong team. And that's it. We're cardiac care and we're saving lives. One Heartbeat at a time. We happy to see you if you have any questions