Filip Peters Presents Acorai at LSI Europe '23

Transcription

Filip Peters  0:04  
Thank you. We have about 1000 pronunciations of our name. Acorai is one of them. Acorai. So whatever floats your boat. My name is Filip Peters. I'm the co founder and CEO of Acorai. We are developing a non invasive intracranial pressure monitoring device to help improve heart failure management. The problem probably needs no introduction to this crowd. Heart failure is a global problem affecting over 60 million patients worldwide. And the US alone costs the healthcare system over 100 billion annually. Over 80% of these patients have diagnosed too late. Over 45% of these patients remain unstable despite optimal treatment, and there is one of the largest and highest readmission rates out of all patient groups. intracardiac pressure monitoring or what's known as measuring the blood pressure inside the heart is the single most important way to manage these patients, but only available in invasive or implantable formats today. The role of intracranial pressures is important in heart failure because it is one of the earliest indications of deterioration in cardiac health. If we can intervene early, we can prevent a lot of these hospitalizations. And we can know the true conditions of these patients cardiac condition and heart failure. That means we can much more accurately manage these patients and help improve outcomes, ranging from reducing complications to reducing the length of stay, as well as ensuring that these patients don't get readmitted to the hospital. The solution is the Accra heart monitor, which is a handheld scalable and non invasive and Accardi pressure monitoring device. We recently received an FDA FDA breakthrough device designation for this device. At the end of the day. What we're offering to the in hospital workflow is a device that can help reduce treatment complications, we can reduce length of stay by improving the response to treatment by these patients, and the crucial reduction in readmission rates by making sure that we only discharged stable patients. It is a universal patient management solution, which can be deployed applied across the heart failure workflow, from start of diagnosis to ongoing management in the community setting. The technology is based on what we call the safe sensor system we've borrowed heavily from non healthcare industries such as the oil and gas industry and engine diagnostics. To build a system that's focused on collecting highly sensitive seismic acoustic visual and ECG data. We analyze that raw data using our machine learning models, which have been developed for the past few years, using our proprietary datasets that have been developed through our clinical studies here in Europe, as well as our partnerships with Mayo Clinic and Cedars Sinai to augment those datasets. What we offer is direct estimates of the intracardiac pressures with the primary indication being that of pulmonary artery diastolic pressure, and our secondary endpoints in our study looking at the other intracardiac hemodynamic parameters, such as capillary wedge pressure, right atrial pressure, and cardiac output. As mentioned, we have done a fair amount of clinical validation already. We have run a large pilot study here in Europe and rolling over 400 patients where we have compared our device against the clinical gold standard. So Swan ganz catheterization, right heart cath, what we've been able to demonstrate is that we are able to uphold similar levels of accuracy as existing implantable devices on the market, there's really only one CardioMEMS, which is now owned by Abbott. But every cardiologist we spoken to worldwide have said that if you can keep this up in a global population, then this is considered very clinically meaningful and will help me manage my patients better. As mentioned, we recently received FDA breakthrough device designation based off of this data and have now just commenced our 1200 patient global clinical study, which will give us the data needed for approval not only in the US, but also in Europe. To the important part of how we're going to get paid, right, we've stressed tested this many times I just had a conversation with one of you about exactly this. There is a high willingness and ability to pay for this device within the operational expense budgets of most clinics around the world, particularly so in the US we are pricing the device at around seven and a half 1000 US dollars per device per year. That works out at a pretty decent 600 per month. The vast majority of physicians that we have interviewed and the CMOS that we have talked to have said that proving accuracy equivalents versus the right hat, the right heart cath gold standard is enough to drive a buying decision and that is what we're going after in our upcoming clinical study. The market size tends to be very big when you're talking about 60 million patients globally. The vast majority of those patients are actually here in here in Europe. But of course the US represents a large problem as well for the inpatient use cases load, which is our primary use case and our first beachhead markets, we estimate that the annual Sam is around $750 million dollars, I should say. The subscription price per device I've talked about already is around seven and a half 1000 per device per year. So it fits really nicely into that operational expense budget of most clinics, and some pretty pretty impressive gross margins all around. So what makes us unique here, right, we are the only device that's able to non invasively and directly estimates the intracardiac pressures. About a year ago, many of the heart failure KOLs  around the world came together to define what a good heart failure management tool would look like. Bill Abraham coined the term of root adhering to the five A's. We have done done exactly, that's making sure that our devices actionable, absolutes and accurate and we are so far the only device that's able to demonstrate that and demonstrate that in pretty substantial clinical studies. We have to date raised 4 million US, we've secured a number of grants courtesy of the EU grant system, and that has allowed us to develop this device from scratch. File three granted patents, another four patent families pending and get us to the design free stage. We have recently kicked off our global clinical study with some of the world's leading cardiology hospitals, including five sites in the US two sites in Canada and another five sites here in Europe, we expect to be finished with that study towards the middle of next year, we've already had close to 100 patients enrolled. And things are for once knock on wood, running remarkably smooth there, which means that we will be on the market in the US by early 2025. And shortly thereafter in Europe. We are a originally a tech founded team. And what I mean by that is that we have the technical skills in house to take this product all the way to market and we've we've taken it thus far. We are not a medically background team, which has been a double edged sword in the term that we've made a hell of a lot of mistakes. But but we also come at this problem with a different approach from anyone else. Right, we have relied more on other industries in terms of inspiration for the tech which puts our IP and what we're able to accomplish at a much higher level than everyone else. Crucially, we have we have attracted a fantastic management team that have done this journey before from a commercialization perspective, as well as regulatory and clinical perspective, from bringing a class two device to the markets. We that we also have a fantastic Advisory Board, ranging from some of the world's leading heart failure and pulmonary hypertension physicians. We have a some of the world's leading executives, some of you are in this room. And some some great investors all around who have the right skills to help us navigate not only the product development part of this business, but also the commercialization aspects of this business. We are currently raising a 4 million round and that is to complete our ongoing 1200 patients clinical study, as well as get us to regulatory submissions in Europe and in the US. Off the back of those that data we will be raising a larger 50 million round towards the end of next year, which will get us through commercialization for the first 12 to 18 months in the US and in Europe. As mentioned we have our final hardware manufacturing ready so we are effectively ready to scale that manufacturing up once the opportunity presents itself. We have secured a lead investor for this round who are picking up between 1.5 and 2 million of this round and we're currently looking for CO investors. So if anyone in this room is interested in participating feel free to reach out to me after after this presentation and we can have a conversation and if you have any comments or any questions please reach out to me here it's Filip.peters@acorai.com and I would just like to thank you for your attention