Franz Bozsak, Sensome - Biological Tissue Sensor Technology | LSI USA '24

Franz Bozsak  0:04  
Hello, everyone, it's so great to be here again at LSI. And I hope to present to you send some today and give you some updates of what happened since since last September. So, the great thing about being LSI is I think that everybody in the room can appreciate minimally invasive surgery completely transformed the way that we treat patients today. It comes with the promise of lowering the burden on the patient, but also on the healthcare system, thanks to lower risks, lower complications, and shorter hospital stays, it also completely transformed. Because certain certain treatments such as that of stroke, which can this the way we do it today, it's unimaginable without minimally invasive surgery, but did the same thing also for oncology, and peripheral vascular intervention. Now, what we can we see that there's many upsides to be had from this innovation. However, today, we have to state that there are certain limitations that really hamper the realization of the full potential of these millimeter invasive surgeries. And to tell you what I mean by that, I want to go into three examples. The first one is that of stroke, this patient is unfortunately having a stroke where a blood clot is blocking cerebral blood flow. And the first question that the physician would like to answer before he goes in to take that clot out using mechanical thrombectomy is actually to understand how long is the tracklist is going to treat? And this is not a trick question the same way you can see it, he can't see it either. And other than that, there are other factors that he'd like to understand what central Genuity what's the composition? Is this an ambulance or is actually the actual wall that is diseased. And the reason you'd like to understand that is because we know from the literature that all of these factors can impact the efficacy of the mechanical thrombectomy treatment, except that today, he just doesn't have access to that. Now going from the head into the leg, the physician would like to understand before he starts treating, is he treating an old heart clot? Or is he treating a soft, fresh clot. And the reason you'd like to understand that is that the tools that he has at his disposal to treat this patient depends on the age of the clot. The only way that he has today is basically talking to the patient trying to figure out symptom onset look at the patient history, which you can imagine it's an extremely crude way of evaluating things. And for example, in the case I'm showing here actually lead to the wrong decision. The last example is that of lung cancer biopsy, we want to biopsy we want to bring a needle into the actual spot, the nodule that we want to that we want to to biopsy in the end. So the question we're asking is, where is the lesion. And you tell me, this is particularly of interest when you consider that an early stage 70% of the nodules tend to be in the outer third of the language is hard to reach, which leads to the fact that in up to almost 60% of the cases, we basically don't get a diagnosis from the biopsy, which then leads of course to a delayed diagnosis, while at the same time the cancer keeps on growing. This is why physicians tell us that what they would like to have is actually a tool that tells them that at the moment of the biopsy that they have a confirmation that they're in the right spot. Now taking all of this together, what we will see is that basically today, the limitation comes from the fact that we actually don't have information about the lesion we're about to be treating. And as a consequence, the only option the physician has is to use a trial and error approach. But this trial and error approach has actual consequences for our patients. In this in the case of stroke, we know that with each consecutive pass we're using the patient's chances of a good recovery are actually diminishing. Today, 60% of procedures require at least two passes. And for the hospital, the cost goes up by up to 30%. If we don't manage on the first pass, in the case of peripheral vascular intervention, especially knowing are you handling a fresh start or not can have an impact on long term outcomes for your patients. And for the lung cancer biopsy, low diagnostic yield entails delays and treatment which means on the one hand, the chances of survival for the patient decrease, while on the other hand, the cost of treatment increase. So what can we do in order to go away from this lack of information that leads to a trial and error and basically poses more risk to the patients increases costs to a situation where we have access to this essential information about the lesion to go to what we would call a first pass effect to rake in all the benefits of minimally invasive surgery. Well, you might have guessed it the answer, of course is sensorium. And the technology that we have developed to allow us to have a connected medical device that allows you to analyze, identify and characterize the lesion while you are treating it. To this end, we have taken an impedance meter and we have shrunk it down all the way then we can actually put it onto a medical device to create the smallest tissue sensor in the world. The signals from the sensor, we then combine with our algorithms that allow us to identify the tissues in contact with the sensor. The first device to integrate this technology is called Clotilde. It's a smart zero 14 guide wire for the treatment of large vessel occlusion of stroke, that can you use that any other guide wire to access the cloud. But other than just accessing the cloud, it's also about characterizing the clot losing using electrical impedance spectroscopy. This is transmitted via a transmitter to an outside tablet and on the tablet, our algorithms are then doing the magic of figuring out what the wire is in contact with. How does this integrate into the workflow? Well, perfectly nothing changes, this physician just uses the wire the same way he's been using it just that he gets additional information you can see here on the screen, so that now instead of just accessing the clock with a mechanical device, he actually understands when he is engaging with the clot, what the thread is made of, and then answer that very first question that we that we had, which is where does the clot actually end? Now, we've been able to show that this does not only work on clots, but also other types of tissues vascular as well as tumor and cancer tissues. So where are we We're just about to finish up. Our first mn clinical trial will basically down to just a couple of patients left. What will happen over the next few days, we had so far zero server events related to the device or the procedure, and DSMB is making sure that we are conducting this first in human trials safely. We've raised over 70 million euros to get us to this point to date, and announced last year a partnership with Asahi and tech one of the best guidewire manufacturers in the world with whom we will be building the commercial product for the market. We also got FDA breakthrough device designation back in 2021, showing you that the that the US would like to have this device and will help us get it there were a team of around 30 People all extremely enthusiastic about their work with various backgrounds, very international, you can see many engineers, and PhDs covering all the different backgrounds that we need from data science, microelectronics, biology, all working together to make this work, of course, never lead engineers to the work alone, right. Which is why from the start, we've been working with the best physicians in their field to develop a device that they actually would like to use. We are also accompanied by veterans of the medtech field that helped us in the development of our strategy. And with this team, we were able to attack extremely promising markets. The first one that I have of stroke and neurovascular, which is which is a market with very active strategics. Because there's a huge growth potential. Today, we're barely treating a little bit more than 10% of patients that actually should be treated. And four cents on this poses a market opportunity of $3 billion. Going into the peripheral vascular market, we have a similar situation again, many active strategics, the market is even younger than neuro market, so is less consolidated. And here the same growth potentially because again, we have just barely treating 50% of the patients that we should be treating, and Facism. This is a similar market opportunity. The last one in lung cancer. New pretreatment power paradigms and robotics are really driving the interests of strategics. In this market. With increasing screening programs, the demand is becoming bigger and bigger, especially for those early stage, smaller nodules. And for some, this is an opportunity of about $1 billion. Now, the way that we capture this value is by licensing this technology to those strategics and work together with them to bring this to the patients around the world. Now, we've been building this technology over the last 10 years from the ground up, bring it to all the different stages. And we are right now at a really pivotal point where we are finishing up our first demand trial in neurovascular. But we also started just last year, our first inhuman in the peripheral vascular system. And I'm going to be flying to Australia justness next week to start our trial in in the lung cancer space. So now you're asking the question, can I be part of this revolution? And the answer is yes, we will be racing around before the end of this year to bring this device to the EU market. Prepare submissions for FDA and PMDA in Japan and also continue the development of the new indications in lung cancer and peripheral vascular intervention and help with that, that you will be come and see me to figure out how you can be part of this revolution. Thank you very much