Video Transcription
Filip Peters 00:02
My name is Filip Peters. I'm the co-founder and CEO of Acorai. We are a medical device company out of Sweden. The name Acorai comes from a combination of three words: acoustic, core, and AI. And that is really at the core of what we do. We're listening to the heart with the help of AI. A brief note here: we're FDA breakthrough device designated. We raised about 13 million from external investors to date. We're 20 full-time employees spread across Europe. We've enrolled about 1,800 patients across 14 hospitals in six countries to date, and we have a solid patent portfolio. Below, here are some of the stellar partners that we work with, and with that, we'll get started. I'm sure most people in here know someone that has heart failure and are aware of the incredible complexity that comes with managing these patients. They are by far one of the most difficult patients to treat and manage, and they account for the vast majority of costs in the healthcare system, particularly in the U.S., and also a high proportion of the readmission rates. About 40% of these patients are inappropriate to discharge despite the best efforts of our cardiologists and nurses. What we know for a fact is that the pulmonary and cardiac pressures help us evaluate and stabilize patients and can help us reduce readmission rates, and that is at the core of what we help we can do for the healthcare system. Current, reliable methods are both costly and invasive, either through implantable sensors or through right heart catheterization, whereby you put a Swan-Ganz catheter into the patient's heart to measure these pressures, and we are, of course, trying to do that all non-invasively. If we look at what these cardiac pressures are and what they do at the core, they are a very early and very sensitive indication of heart failure and how patients are responding to medical therapy. This is sort of the traditional idea of being preventative about heart failure and seeing pressures used in that way. We have identified an overlooked part of the market segment where we believe that the intracardiac pressures can be used to help treat the patients from the day that they show up in the hospital to the day that they're discharged, and there is a large unmet clinical need here to reduce the cost of managing these hospitalized heart failure patients and make much better decisions. So how are we doing this? Well, we are doing this non-invasively, and we're doing it with a device that is a handheld device that you place on the patient's chest, alongside the sternum, under the collarbone, and within a few minutes of recording, we are able to provide a non-invasive estimate of the cardiac and pulmonary pressures, primarily looking at the pulmonary artery diastolic pressure, but we also have our eye on capillary wedge pressure, right atrial pressure, and potentially cardiac output further down the line. So from a value proposition perspective, what are we looking to accomplish here? Well, in a nutshell, as I mentioned earlier, it's about improving decision-making and making that decision-making more efficient and more accurate. This will, by extension, reduce the cost of managing primarily in-clinic patients to start off with. It will help us reduce readmission rates and adverse event rates associated with these patients, and we believe we can reduce the number of unnecessary invasive procedures and complications associated with those procedures. If we just look at the way the current clinical pathway looks like for these patients, it is a myriad of imperfect methods and tools that are used in current clinical practice. We believe that we can help improve this workflow substantially. But as you can see, the average length of stay in the U.S. is around seven days. In Europe, we're much closer to 14, and in Japan, we're upwards of 25 days. So there is some heavy work to be done here to improve things. So how do we fit in? Well, the goal here is really to get rid of a lot of unnecessary and unspecific tests that are done in the workflow today and get these patients to the treatment and care that they need much quicker and with a high degree of accuracy. On top of that, we believe that really, for the first time in history, offering non-invasive, continuous cardiac and pulmonary pressure monitoring will allow us to much more proactively manage both diuretic adjustments, but also guideline-directed medical therapy for these patients, and ultimately, again, to this crucial, repetitive topic of improved decision-making, making sure that we're only discharging the patients that are stable enough to be discharged so that they don't come back into the hospital just a few days later. So to summarize, we believe that improved decision-making will lead to fewer admissions, reduced costs, and improved quality of care. Okay, so how does this thing work? Well, we've been able to patent a technology which is a first-of-its-kind technology that leverages a completely unique combination of non-invasive sensor technologies. We've borrowed heavily from the oil and gas industry in terms of insights on how to approximate pressure and fluid dynamics non-invasively. We have coined what we call the SAVE sensor system. SAVE is really just an acronym to help us remember the types of sensors that we use, which are a combination of seismic cardiography, so looking at the chest wall vibrations of the skin on the chest, looking at acoustic signals, so listening to the flow of blood and approximating pressure from that, and visual and electric sensors. Because we have trained our machine learning models on thousands of measurements versus the gold standard, we are able to attain very high levels of accuracy versus the gold standard, which is that right heart catheterization procedure, and which then allows us to estimate these cardiac componentary pressures non-invasively. We validated this in two studies. Our pilot study in Sweden showed some very high correlation, high levels of sensitivity and specificity versus the gold standard, and accuracy levels on par with the implantable sensors on the market. We used that data to get our FDA breakthrough device designation and joined the TAP program in the U.S. And then we kicked off our global Capture HF study, which is a 1,500 patient study across 14 sites in six countries. We are almost done with that study. We have about 50 patients to go in enrolling, and we will be done by October. We expect that study to show us that, yes, this does not only just work in Swedish patients, but we're able to cover the Arkansas and the Texas of the world as well. We believe it's a global $10 billion market across the different workflows. We are, of course, targeting that in-hospital workflow first, as we believe that is where the unit economics make the most sense. That is where the incentives are very much aligned for us, and where we believe that there is the ability to pay. We believe that we can leverage existing DRG codes for heart failure hospitalizations to make an argument that we can reduce costs, improve throughput, reduce length of stay, and keep hospital beds open for much more profitable and elective procedures. And this has been validated in multiple customer interviews with chief medical officers of hospitals, cardiologists, and nursing body assessment committees. The team consists of, as I mentioned, we're about 20 people globally now. We're a core team of six, and we've all been on this journey before and taken medical device startups from ideation all the way to FDA and CE marking. We're a technical team by nature. So we have taken this device from its very inception to where it is today. A number of us have gone through both class one to class three device processes from a regulatory and clinical perspective. So this is my cheekiest slide. This is how we like to describe the kind of competitive landscape, the way we differentiate ourselves. And if there's one thing to remember, it is that we believe most of the field to be over-patched and under-engineered, and we're almost the opposite. We're almost over-under-patched and over-engineered. But the reason we have chosen that is because we have realized that there is such a huge need for accurate, absolute, and actionable outcomes and results from a device such as this, and there is an ability to pay. There is also a much higher acceptance for a slightly larger form factor, which is why we believe we have the best device for this market segment, and we have the clinical data to prove it. So looking forward, you know, I'm not just here to make a nice presentation, but we want some money. At some point, we will be kicking off a raise beginning of next year, off the back of our clinical study report. So we will have the results published. By then, we expect to have our Quality Management System certificate in place. We will be done with the design output stage of our product development for the final generation of the device, which is the one we'll be going to market with, and we will have our category three reimbursement coding application for the U.S. markets submitted. And with that said, I just like to thank you. If you have any questions, please feel free to reach out to me here at filip.peters@acorai.com, and because I'm Swedish, it's a Filip with an F, and we'll leave it at that.
