James Greene Presents MedLumics at LSI Europe '23

Transcription

James Greene  0:05  
So MedLumics is a medical device company, we're focused in the area of treating atrial fibrillation with a very unique and proprietary catheter catheter system. Why we're here, we're here we're raising 12 million euros to basically support the finalization of the preclinical development of the product. And then we're going to advance into our clinical studies to get initial clinical validation of the device, the device actually combines uniquely combines RF, RF energy along with the rapidly emerging energy energy source of pulsed field ablation, it actually provides the clinician a clearer vision, it gives them the ability to actually actually evaluate the tissue underneath the surface of the heart where they're bleeding, bleeding tissue, it'll reduce the complexity of the procedure, it improves the safety procedure, and it'll improve the efficacy of procedure. And that's really our goal. Our goal is to make the make the make the procedure simpler, but it's actually reduced the rate of AF recurrence. So we look at the AFib market is a very large market, it affects about 35 million people worldwide. It's has a huge, it has a huge economic burden to all the United States, Europe, and so forth. It's also a very large expanding market with a high incidence rate annually of about 4.7 million people. When we look at the current therapies that are available to treat to treat atrial fibrillation, you have anti arrhythmic drugs, which have a very low success rate, you have catheter ablation, which is better, but it's technically difficult. And the rate of occurrence is very high. What are the reasons for that it's it's a very blind procedure in terms of being able to evaluate directly how the therapy is being delivered and the effects of that therapy, there's a high cost associated with redo patients. 20% of patients, you know, have two recurrences of AF within the first year. And then, and then, when you look at the five year picture of that 75% have recurrence of AF within five years. So it's totally unacceptable. And it really makes it difficult to address the significant long term effects of having AFib, which are significant sequelae. So you have greater risk of heart rate of heart failure, two times greater risk of stroke, that's one of those other things which people are very afraid of having. So we really need to solve this issue in terms of reducing the recurrence rate of a large market, a growing market, really underserved market, only one to 5% of patients that have AFib actually received a catheter ablation, yet, there's $4.1 billion in catheter sales annually. It's really dominated by four major players in the market. And then when you look at energy sources, right now it's dominated by radio frequency, which will still remain to have a role, but right now, there's only one major player that has a commercial commercial device and PFA that'll change this year, if so that PFA piece of the pie will start to expand. And we want to take advantage of both of those energy sources. radiofrequency is really characterized by heat. So when you apply thermal energy to the tissue, if you can't really assess directly in real time how that energy is progressing, you can have you can have some very serious complications, such as esophageal injury, you basically burn a hole through the esophagus, which is very frequently a fatality for the patient. So that's one of the limitations with radiofrequency. It's very versatile. And when you look at cryo, we're going to apply, we're going to freeze the pulmonary vein using this type of thermal energy. The challenge with cryo is that you're actually putting it into the pulmonary vein, which is actually an artery. So when you deliver when you deliver, deliver freezing energy to that you can create damage to the pulmonary vein, you can create pulmonary stenosis. This system that you see here is what we call a one shot device. Very simple to use, very efficient, but it does carry also some complications along with pulsed field ablation. I'm sure everybody here has probably heard of that that's tracking the treatment of afib. It's a non thermal energy, it's very efficient, it can be delivered very fast. It's safer, because it's really selective. It's only going to ablate the tissue that we want to that we want to ablate and that those are cardiomyocytes, it's going to leave all the other structures alone, which makes it a safer, safer choice. The challenge with pulsed field it is very fast, you apply it you lose all the electrical activity in the heart and it gives you a false sense of security that you've created a durable lesion with PFA. PFA lesions are not immediate, like RF and cryo, they they mature over time through a process of programmed cell death. So tissue studying can give you a false sense of security that you've actually created as a adorable lesion. And that's the challenge with PFA and that in that challenge was actually born out and one of the first randomized clinical studies between RF cryo and PFA, this data was recently released at the ESC in in Amsterdam. And it really showed no improvement in terms of AF, reducing AF, AF recurrence in all those energy sources. Granted the device use was, which was a first generation product, it should improve. But there is also a significant amount of serious adverse events as you compare, as you compare it with the other other modalities. This is our system, it's a complete system. When you look at the catheter, the catheter incorporates optics into the tip of the catheter. So it gives the physician a 360 degree view of where their catheter where their catheter tip is positioned against the tissue. I try to use my laser pointer here, which Yeah, there we go. This is an A scan on our GUI. So this actually gives them information in terms of how the tip is positioned against the tissue, is it stable, and do they have contact contacts extremely important and making an efficient lesion and if it's not stable, it creates it creates a bad lesion. So it gives them information in real time that lets them make real time corrections to how their catheters position. Here you have, you have our groups will go back, there we go. So here you have an estimated lesion depth indicator, we can actually predict the progression of the energy source in terms of in terms of depth of penetration into the into the heart when using RF ablation. It's dual energy, so you can use RF or PFA in the same setting on the same catheter. So it gives the physician a lot of versatility. When you look at the a bit of the science behind it, we use polarization sensitive OCR, so we're using we're using optics through the catheter. And what we're measuring is we're actually measuring the the structural, the structural organization of the tissue underneath the surface that you're ablating. And as we ablate as we apply energy, whether it's our for PFA, we can we can see the disruption of that tissue and we can correlate to depth of penetration speed or speed of ablation. And we can also correlate it to do we have have we electroporated cells enough so those cells will not reconnect after a period of time. So if we look at the way that we use this, in PFA, this is our GUI. This is a property that we measure called birefringence. It's the optical properties that are exhibited by tissue which is organized as we ablate we almost immediately see the drop off that birefringence signal, and in 21 seconds, we deliver a full PFA packet, which gives us some very important information. We've been able to we've been able to assess with our preclinical data that if we lose 20% of the birefringence signal with PFA, we can accurately predict that you have a durable PFA lesion. Going back the challenge with PFA is that you apply the energy use electrical signal, you wait for a period of time 20 minutes you do an adenosine adenosine, check to see if you can stimulate reconnection, if you can't, the clinician feels that the lesion is durable. The challenges, PFA develops over time. But we actually aren't measures have we electroporated those cells enough so they cannot reconnect. And this is one of the key challenges that which is only solvable with this technology currently. So using optics allows us to do that all in real time. And so the system because it's an optical system, it can also be used in a diagnostic mode. So when you make your when you make your ablation line, this is an SCC superior vena cava. So making an ablation line here you can see these red dots. So what's really nice about this system for the clinician, is that they make their ablation points, and then they can use the system to go up and track to see okay, have I have I missed a spot? Have I covered all this? and when you look here, when you look above the line, and we're going north to south, you can see the birefringence signal here so there's no ablation made there nor nor was it intended. Over the ablation light, you can see a clear demarcation where the tissue has been denature eyes and having a complete lesion. Again, going below the line you can see the the reemergence of the birefringence signal. It's very sensitive, and it's all been proved out in histology with with 60 animals have been treated acutely and chronically too bored to bear this there bear this out. One of the things I'd like to point out is if you look in the lower left hand corner, you can see a big red dot in, the middle of that lesion that was created that shows the selectivity of PFA, the PERT the the blue part is the ablated tissue that we intended to ablate. The red part is the phrenic nerve which we wanted to preserve. So it is a very selective technology and the safe technology. This is really one of the key features of the system. As I said we can really detect whether you have a durable lesion or not. So when we ablated this particular tissue here, we saw that in the upper left hand corner, we hadn't lost 20% of the birefringence signal. So from our perspective, we knew that that lesion was going to be reversible. But the EGM activity showed It is being being isolated. We let that stay the way it was. And then after 90 days, we went back exercise the heart and actually looked at it indeed, in fact, it was, there was a reconnection right at that spot. So it shows that it can actually predict, predict what's going to happen to that lesion as you're treating it. And that's what the clinicians need. They need something which they can look at now, to determine whether they need to read dose to be able to complete a complete make a complete lesion. Our accuracy with RF is is significant, it's 97%. It's very specific and sensitive. Using RF ablation, we have a very accurate estimated lesion depth prediction model, which allows the clinician to see in real time how far they're progressing with RF. And keep in mind, it's thermal. So it's very important to know how fast it's progressing, and how deep it's progressing so that you know that you have a lesion which is transmural. But let's say not to transmural, where you create it, you create an injury like apoptosis. If we go to PFA, again, really just focusing on one point here, in 82%, of the an 80% 82% of the lesions where we didn't lose 20% of birefringence, those all related into reconnections. When you look at EGM, or the electrical activity, which they measure success by now in the clinic, only 11% were specific enough to know that you had a lesion which was not durable. And that's really that's really the the advantage of this system is that we can actually predict that in real time at the time of treatment. So you know that you have a durable scar before that patient leaves the cath lab, which will reduce the rate of recurrence. And it'll address some of those issues that we showed on the first first couple of slides. This is our timeline. So right now we're, as I said, we're raising 12 million that 12 will cover the rest of the development to prepare for clinical study. And then in 2024, we're going to have a couple of we're gonna have a few different clinical clinical trials, small trials to be able to show proof of concept clinically with the system, we will look at using the using the device for RF pure and using the device also for PF pure. And why are we doing that we're doing that so we can educate a clinic clinician how that system works with both of those energy sources. We'll do the three month Remapping. So we'll be able to show we'll be able to prove out the predictability models that we've put into put into action. And then we'll we'll generate a hybrid study where we'll have 25 patients where their physician will be able to use the system as they want to be able to use RF potentially to thicker areas of the heart, where a depth of penetration is important, and PFA in areas where they want to where they want to protect adjacent structures like with the pulmonary veins, so they'll have complete control of how they want to use that energy source. Also being able to use RF and PFA together can have the possibility of further extending you the depth of PFA, which they will make PFA to be able to address lesions in the ventricle, which is a very much untapped market that we're going to go after. But first we're going to we're going to focus on AF. We've got a really good team internally. We're based in Madrid, we have a manufacturing partner in California. We have three of the PIs for the pulsed field ablation studies at Medtronic, Boston Scientific and biosense Webster who are integrated into our team, work with us on a regular basis on all of our preclinical work and advise us, advise us accurately on what's needed. And we've got a great set of investors who are fully committed to the project. And I'd love to be able to answer more questions about in more detail about the technology and what we're planning for the next two years. I guess bottom line in 18 months we'll have a very strong value inflection point where we can either create a strategic exit or have enough clinical data to then be able to raise the capital necessary to do the PMA study after that. Thank you for your attention.