Video Transcription
Frebus van Slochteren 00:02
Thank you very much for being here. My name is Frebus van Slochteren. I'm the CTO and Founder of CART-Tech. We're based in the Netherlands, and what we do is we make a vendor-independent platform for augmented fluoroscopy. So what it basically does is we add a layer of color to X-ray images. X-ray is a well-known technology, but basically it shows bone and contrast media. We were founded in 2018; we are university-based, started from a university based in Utrecht, and what our mission is to reduce the burden of cardiovascular diseases with image guidance technology. We have the CART-Tech platform, which is basically, when you think about it, the Google Map system for cardiologists. We have an existing patent family granted in the US and in Europe, trademark registration, and trade secrets. Our regulatory pathway is a Class IIb medical device, and it's granted in the EU. Of course, we finished the notice center, RCT, and another study in another field. The first problem that we are focusing on with our technology is the non-response to cardiac resynchronization therapy. That's therapy for patients with heart failure; a three-lead pacemaker is implanted into the heart, and it's very important that the third electrode should be put on the optimal side, on the left ventricle that is outside scar tissue, and in a late activated segment. The typical clinical or health status of a heart failure patient is that heart failure kicks in, the heart function decreases. At some point, the patient becomes eligible for CRT, and then it can either go up so the pacemaker works, or decrease down in 30 to 40% of patients. That is the case. Unfortunately, there are 12 million of these devices implanted each year; the non-responders mean a very high burden, not only for themselves, as they keep having heart failure, but also for society. Well, what's the underlying problem? I already said it in my introduction a little bit, is that when you do the workup of the patient, so the clinical workup when the patient enters the hospital, there's a lot of imaging done. It's MR, CT, very high resolutions, showing a lot of detail about the tissue constitution of the patient, but what it doesn't show—so once the patient goes to the interventional department when the pacemaker is being implanted—then all that information is not available. Yes, it's like there is a brick wall in between those two departments in the hospital, and that's literally the case. So the physician has a CRM system. It can be very quickly. It's cheap. It uses it every day, but it doesn't show actually the crucial elements that it needs. What we do with CART-Tech, we solve that problem by leveraging the MR and CT data in the cath lab, so a physician can easily drag and drop a CT scan or an MR scan into our DICOM destination in the PACS system. The system analyzes data as a segmentation, makes a map of that heart, shows the tissue constitution—so where is the scar? Where is an activation wavefront? How is it going?—makes a 3D model of it and sends that back, accompanied by a patient report showing to the physician, prior to the intervention, if the patient is eligible, where the lead should be placed. And during the intervention, the whole 3D model can be fused with X-ray so that the physician can appreciate, "Here I should place my electrode." The current status is that we've done a lot of research. We have shown in our latest achievement, a randomized clinical study, that the system works—so fewer leads, many fewer leads are placed in the scar, and also the clinical effect—so the reduction of the size of the heart is significantly better when our technologies are used. Technically, we have a processing pipeline in the cloud. It's infinitely scalable, so we can do a lot of patients every day. We've completed the whole pipeline from imaging to the intervention. It's easily integrated into the hospital workflow. And as I said, CE mark commercially, because we have a CE mark, we have done a lot of demo procedures with KOLs in Europe. We have sold one system currently in an Italian hospital. The target market that we are working on at the moment is cardiac electrophysiology. So the first intervention in that area is cardiac resynchronization therapy. As I said, we did an RCT. We do significantly better in our image-guided group. And remarkably, there is a patient category, the Class II patients, which are without our technology less likely to respond, that become now eligible for the therapy. So that group is a little bit undertreated at the moment, but we, with our technology, are getting those patients back to the CRT therapy. Then there's atrial fibrillation ablations, which is another intervention in this cardiac electrophysiology space. We have done a clinical trial there and left bundle branch area pacing, which is a new way to implant pacemakers, but also rely on information about tissue. So we also have a device under development in that area. The second market is interventional cardiology. We have identified three interventions which could really benefit from our technology, and all of them, we make the procedure safer, more effective, more reproducible, and we give trust to the physicians that they're doing the right thing for the patient. The business model that we envision and that we are currently using, actually, is a combination of a hardware device in the cardiac cath lab, in the cloud portal usage through which the data is analyzed. So that combination is offered to a hospital for 20,000 euros per year. But if you buy for four years, you get a 20% discount. Every new indication is added to that with the same matter of pricing. So then a new indication is 10,000, but for four years, 7,500. We are aiming at patients and hospitals that do, on average, 30 patients per year. That is a little bit average in hospitals that we work with. If larger hospitals do more, they get an extra bill at the end of the year for the surplus that they did. This is the money that we envision to need in the work that we want to do in the coming two years: 3 million. We want to really focus on the transition from a research company to a commercially active company. We still want to do a little bit of work on the platform, automate it better, do more automation in the cath lab, so that nurses are really eager to work with the system and their work is made easier instead of extra tooling. The clinical feedback is very positive. We have KOLs all over Europe. Our exit strategy is with all the med tech companies, so the device companies, but also the vendors of the C-arms and the MRI equipment. We have ongoing discussions with all of them, even Abbott financed one of our earlier studies. This is the team that we do the work with, together with Johan Maas, who has been working for Medtronic for 19 years in the CRDM business. We lead together. The other members are software developers, QA, and clinical studies support. I'm really happy with this team. They've been with us for, yeah, for a long time already, and yeah, we've proven that we can together do a long stretch. This is the end of my pitch. Yeah, if you're interested, I would like to tell you a lot more about the company and what we're aiming for. Thank you very much. Applause.
