Amos Ziv, CardiaCare - Closed-Loop Neuromodulation Device | LSI Europe '22

Transcription

Amos Ziv  0:00  

Good afternoon, everybody. Thanks for coming. And thanks for the opportunity to present CardiaCare. So, CardiaCare is the world's first wearable that actually delivers treatment therapy. I'll say it again delivers treatment to treat patients with cardiac arrhythmias. So we're deploying non invasive neuromodulation to the wrist, we're targeting the vagus nerve and we're reducing atrial fibrillation burden and incidence. So a population is the most common cardiac arrhythmia is a progressive disorder, affecting more than 30 million people around the world and it increases the risk of stroke and heart failure, and overall death. The economic burden on the healthcare system is enormous. And existing therapies, although quite advanced, it still are lacking efficacy. So the patients themselves suffer from debilitating symptoms like palpitations, chest pain, anxiety, and the limitations of current therapy which involve both drug therapy and therapeutics are high. So drugs the anti arrhythmic drugs, they work initially, and then they stop working with you need to change drugs to increase dosages, and they're not side effect free. procedures like cardioversion, and even ablation have highest high failure rates, cardioversion, to springs patients back to normal rhythm. But the event recurrence rates are very high up to 80%. At one year, ablation, which is the gold standard treatment these days, he's very successful in the first year, let's say 80 to 90% success rates, but that five year success rates of ablations are low, so almost 50% failure. So clearly, there's a huge unmet need. And this is where cardiac care comes in. So cardiac care is the if it's going to be a physician prescribed device, it's positioned to treat patients as adjuvant therapy to current to current standard of care because of such such an unmet clinical need. So imagine wearable that can be used at home for both monitoring patients and treating patients in order to reduce symptoms, hospitalizations, procedure costs and improve patient quality of life. So that's exactly what we developed in CardiaCare. What you're seeing on my wrist is what you're seeing up there. This is the first world's first non invasive neuro stimulation device that actually treats patients non invasively. With a complete closed loop system for both monitoring and treating these patients and optimizing and personalizing care in the future. Also, an account can stems from more than 15 years of clinical practice and know how from the real world. So this is not something that came out of some idea of an engineer, we saw this working on patients and we said okay, let's see if we can actually validate this and monetize this. So a little short description on the mechanism of action. The vagal nerve stimulation has been shown the ability to reduce over sympathetic drive which is one of the major triggers of atrial fibrillation episodes. This has been shown on multiple sites around the body, we know the innovation was making a new comeback. Also ear stimulation. CardiaCare is actually targeting a novel approach, which has been shown in the past in animal models to reduce the F burden and other arrhythmias as well, or it has been shown invasively we did that for the first time both in animal models and in human humans, as I'll show you in a minute to show that median nerve stimulation actually targets the Vegas axis or the steroid Vegas axis and reduces AF burnin incidents. So we finished finished first in human clinical trial. Basically, we had patients come into the ER with symptomatic AF. They were screened with a 24 hour ECG for atrial fibrillation, they were cardio averted, meaning they were brought back to normal rhythm to sinus rhythm, and then got our device for eight weeks at home for both monitoring and treating them themselves. So what we saw again, this was a small first human. After years of clinical observation, we actually came up with this study design, and again, very successful, not surprised to us, we're seeing reduction of almost 50% and AF recurrence. At eight weeks, we've seen acute reduction where patients are being the control their own control. In this case, we're seeing a reduction of premature atrial beats, which are precursors of AF that trigger the eye of bouts, which we're following. We're seeing almost 50% reduction, and these instances in these and both an acute and also in the cumulative. You can see on the right bottom, the 24 hour ECG of one of these patients. So in terms of compliance, patients love the device. We had trivial compliance in terms of measurements and tools treatments of nightmares. sent to 97%. So, and safety was excellent. And in addition, in addition, compliance as I said, we're I didn't overpass 510 K denovo path towards FDA. We're targeting at population of paroxysmal atrial fibrillation population, which is most of the patients around a million new patients each year in the US alone. Again, AF is projected to be in world epidemic involving more to 70 million people around the world to 2050. So, in terms of reimbursement, or initial analysis indicates that we can go for both device sales, and a SaaS model for monitoring device sales under existing hickspicks codes of DME and also ongoing SaaS models where the physician can actually build under RTM's remote, therapeutic or RPM remote patient monitoring codes up to $120 a month for looking at the data, especially with relation to therapy. We have, we have granted patents on the engineering aspects. We have written patents on methods. And we have patent pending PCTs on the algorithms and machine learning and the AI that we're actually devising in order to optimize care, personalized care from a distance. A very strong team come from both our commercial aspect, our engineering aspects, you can see the logos of our team, our world leaders KOLs in their field, both from Europe, from the US and from Israel. I think behind this slide is about 12 exits in the medical device field. So we're really backed by a very strong team. Overall, we're raising $5 million. So far, we've raised $2.3 million dollars, which got us quite far is as you can see on the device and in terms of we completed our first and humans clinical study, we're raising five additional million dollars in order to move it to the next value inflection points, which will include the results for my next sham controlled multicenter study on 60 patients and we're going to do a 510 K for the ECG quick and dirty this year. And in addition, work additionally on design freeze towards the pivotal study and also more on the closed loop algorithms. So we are CardiaCare to saving lives one heartbeat at a time. Thank you