Filip Peters Presents Acorai at LSI USA ‘23

Transcription

Filip Peters  0:00  

Hey guys, my name is Filip Peters, we have a few different pronunciations of our company name around the world. Acorai is one of them Acorai another the French go for the Acorai. So you can say whatever you want to say, but I am the CEO and co founder, we are in the business of heart failure management. And the problem that we're addressing is a well known one. It isn't one that is leading to substantial losses to the entire healthcare system. And it is really a completely broken workflow. And that starts from from the beginning of diagnosis, which is late, lengthy and costly to the in hospital management of these patients, which is typically inexact and characterized by uncertainty to the outpatients and, and treatment in the community setting where there is further uncertainty in these patients. The unmet need is to be able to monitor these patients better, one of the ways to do that is through the intracardiac pressures. And to do that non invasively. The intracardiac pressures are the single most important vital signs when it comes to managing these patients. And this has been shown in multiple clinical studies over the past few years, and there is a large clinical acceptance to managing heart failure patients with the intracardiac pressures. But the solutions on the market remain invasive, they remain expensive, and they're only available to a certain set of heart failure patients. The solution is the Acorai heart monitor, which is a non invasive intracardiac Pressure Monitor is a handheld medical device intended for use by healthcare professionals within the in clinical setting, we're able to provide our direct estimates of the intracardiac pressures, including the pulmonary artery pressures, we're also able to identify elevated levels of capillary which pressure as well as elevated levels of right atrial pressure, effectively giving you as a managing cardiologist or nurse or hospitalist a very holistic view of your patient's health and better understanding of how they're responding to medication and how they're actually feeling. We have three granted patent families covering the device and another four or five patent families pending. It has built on what we call the safe sensor system. Save is really just an acronym to help us remember the types of sensors that we embody into this device. So we're using seismic sensors, acoustic sensors, visual sensors, and ECG sensors, analyzing that data using our machine learning models, and then we're able to output these estimated intracardiac parameters. We are the only non invasive handheld device that is able to estimate the pressures directly. And that is really one of the most important differentiating factors. And one of the most important things that have come up in our conversations with cardiologists when it comes to driving better patient management for them. We have strong data supporting our claims, we have enrolled over 300 patients in a clinical study that compares our device against the clinical gold standard, which is an invasive right heart catheterization procedure. We have enrolled over 300 patients to dates, two high volume sites in Europe. And we've also done a close to 900 Total measurements looking at changes in pressures after certain interventions that are typically done during this procedure. What we're seeing, as I mentioned, is non inferiority to implantable devices that are currently on the market for pulmonology, diastolic pressure estimation. We're seeing superiority to standard of care in identifying congested patients. We're also seeing superiority to standard care enrolling in and screening for patients that have heart failure, and elevated levels of pressures. And we're able to do this with a tool that's really easy to use, and has high repeatability, helping avoid a lot of the issues that we have many of us experience with ultrasound over the past few decades. This is a slide that that brings up a lot of conversations with potential investors. It is a statement that we have tested multiple times now in over 100 customer interviews. And I think what's what's important to understand about the patient group that we're going after is they are typically loss making patients for hospitals in the US, the hospital, types of hospitals that we are going after are in the regions where Adam is present. So the south of the US the Mississippi is an Arkansas of the world where you have predominantly Medicare and Medicaid patients that come in as heart failure patients, and the hospitals just aren't getting paid enough to manage these patients. So any tool that can help these managing cardiologists be more efficient in the workflows help keep these patients out of hospital and improve profits for this hospital. Whilst not adding extra workflow. I think that's the crucial aspect is is very interesting to these and we see a large market to sell directly to these cardiologists based on operational expense budgets and very low need relatively speaking to drive revenue through reimbursement codes. The market itself is is very large. As I mentioned that there's 6 Million Hearts for the patient, the US today grown to 8 million by by 2030. Globally, we're talking 60 million. Heart failure is a global problem, although the US is tends to be a leader in that space. And based off of the types of customers that I was just mentioning, we estimate that the addressable market is just under 3 billion per annum. And the longer term total addressable market is closer to 15 billion as we expand our workflows to include the primary care settings as well as the outreach outreach setting. The device will be priced at a $7,500 per year and fitting nicely into the operational expense budgets of these clinics, bringing down our total sales cycle. And as I mentioned, we have done a lot of stress testing on this to make sure that there is a market. Cardiologists are notoriously known for wanting new toys but not wanting to pay for them once once push comes to shove. But decision makers and chief medical officers around the US are excited about we do based on the accuracy levels that we're currently able to demonstrate. As I mentioned earlier, we are uniquely positioned in this space, and that we are able to retain the clinically meaningful outputs of the intracardiac pressures, like our invasive competitors, we're furthermore able to do this in an in hospital setting, which is just not possible for the implantable sensors. And we're able to do this non invasively, but also retaining a certain ease of use and scalability, which means that there's minimal workflow friction, and this is something that you carry along with you, as you do your rounds and go to see your patients. In terms of the product timeline, we have so far gotten to a design freeze for the hardware. And what we're doing now is we're extending the patient group that underlies our machine learning models to a global population. That means extending the study from 300 patients a day to over 1000, later this year, including top sites here in the US, as well as sites in the UK, extended Europe, as well as Asia, we expect to be on the markets by q1 of 2025. And that's when we'll start commercializing in select markets in both Europe and in the US. We have a multi discipline management team that supports us throughout this journey. We are a technical co founding team. And what we mean by technical is that we have the technical skills to bring this product all the way to market. And we have brought it this far all through in house development and with a fairly limited budget of 2.5 million. But we've also built a team that have experienced and successful experience of bringing medical devices to the markets, not just from from our invasive competitors CardioMEMS but but also with a fantastic clinical team and regulatory team who have taken class one to class three devices to the market before. We're currently looking for 7 million US dollars, which will get us all the way to market including CE marking and our de novo grants. And we expect to start commercializing in q1 of 2025. Our current investors include heart failure pharma companies, medtech VCs in Europe, as well as private investors. And as I mentioned, we have had 2.5 million US dollars invested to dates and a number of grants, courtesy of the European Union. And just to summarize, what I've presented here today is really first of its kind heart failure monitoring platform that doesn't just have the potential to manage heart failure patients and produce the intracardiac pressures, non invasively, but can be extended beyond that to cover all cardiovascular disease. We have the potential to improve the entire heart failure workflow by improving early diagnosis and treatment of these patients. There is, as I mentioned, a high willingness to pay and ability to pay by decision makers around this country and other countries around the world. And what we will be able to offer these these hospitals is really improved management, which will, by extension lead to reduce readmissions, improved mortality rates, and improved overall survivability rates. This is a huge problem as we know, and it has been an overlooked problem for a long time. So I welcome you to contact me and inquire about any ways we can work together. Thank you very much for listening and I look forward to being in contact with you