Ran Sela Presents Healium Medical at LSI Europe '23

Transcription

Ran Sela  0:05  
I'm Ran Sela, co founder and CEO of Helium Medical and we develop ultrasound ablation platform with primary focus on atrial fibrillation. So I talk tribulation is the most common cardiac arrhythmias. It affects millions around the world where you ever atrial fibrillation or AF electrical triggers originating around the pulmonary veins are causing the atrium defibrillate that leads to blood clot formation that can travel to your brain and lead to stroke. And in fact, if you have a if your stroke risk is five times greater golden standard procedure for atrial fibrillation is called catheter ablation in which a catheter is inserted into the left atrium. And then lesions or scar tissue is created around the four pulmonary veins to prevent from those trigger getting into the atrium. But to be successful, you need to be you need to meet few criterias it needs to be fully circle, it needs to leave no gap, it needs to be permanent, and it needs to be full thickness. If one of those criteria is not met, the patient will be back to a second procedure. And in fact, what we see that the up to 30 or 40% of patients undergoing this procedure will be required to go under a second procedure to complete the isolation. The main failure reason is because lesions were not didn't meet the ideal criteria in that leads to electrical reconnection between the pulmonary vein and the atrium. So currently, there are two main technological groups that are used for ablation. One is the point by point and the other one is a one shot balloon type solution. Even though they differ from one another, they have three limitations in common. The first one is that you have to make contact and a stable contact to ablate. If there is no contact, there is going to be no lesion. And it's not trivial to create a good lesion or good contact because the heart is moving and the patient is breathing. And therefore the lesion is a very, it's very difficult to create good lesion. It also tend to leave gaps between lesion points, which is very clear with a point by point. But even with a one shot ablation, we can see the anatomy that not all pulmonary veins were created equal. That means that it's very difficult to create a circumferential lesion even with a one shot solution. So that leaves gaps the third limitation in common that none of them as any integrated imaging. So you don't know what's the lesion thicknesses, and you don't know what's happening to the tissue during ablation. So it's basically done based on physician experience and expertise. So our solution is different. We use an a different energy modality to create the lesion effectively, we use ultrasound and our main building blocks of the technology is an ultrasound console procedure softer transducer motorized unit and an ablation catheter. The way it works is that we have the ablation catheter, it's connected to a motorized unit. The transducer that emits the energy is surrounded by a balloon just to preserve mechanically position the catheter inside the pulmonary vein. And we have surface electrode to monitor the electrical signals throughout the procedure. Once you're ready to ablate or once you ablate our transducer can do both two things, it can ablate and it can also image at the same time. So once you're ready to ablate, you get a very collimated acoustic energy to precisely ablate only the tissue of interest. So you connect the transducer into the handle rotate, it can create either continuous or point by point ablation of segmental ablation based on the anatomy, the way it looks in the lab, it's connected the sedbuk bedside, and we can rotate fast for imaging we can connect, we can rotate slow for ablation, either step by step or continuously. So when we use thermal chromatic lesion Phantom, you can see our control the step by step lesions that we create, but obviously we can also rotate it continuously continuously and get the continuous lesion. So in the lab in the in the procedure itself, we insert the catheter over the wire into the pulmonary vein. Basically, we start out rotating the transducer. And based on the imaging, the live imaging that we get, we can monitor the distance to the wall and the wall thickness and ablate based on actual tissue parameters, no more guessing or no more relying solely on that physician experience and expertise, ultrasound has also also been demonstrated to monitor effectively Legion formations in that publication that was made a few years ago and we see similar results in our bench testing as well. So the key value proposition that we offer is one, we don't need to make contact fetal tissue to ablate altra sound can just propagate through the fluid through blood and ablate, effectively the tissue. Second, using the motorized unit, we can create continuous lesion. And third of all, we have that integrated imaging to create to create real time monitoring. So the way we see the procedure flow, we don't change anything in the way physician are used to do it today, the insert the cause or the wire, inflate to position, connect the motor unit to linearly translate the transducer back forth by rotating to create the longitudinal and cross sectional images. Based on these images, we will build the 3d the local 3d model, this is the only model physician needed to create pulmonary vein isolation and ablating where at every point we'll monitor the exact changes in the tissue to provide a real score of the effective energy delivery until we create a complete circumferential ablation. So by now we've done numerous some numerical simulation, we see that we have a good agreement between the thermal profile and the actual lesion that we create. So by this point, we know exactly what's the energy dosage are required. We do it in the lab using an XY set platform that we use, we ablate in multiple location, every location, we know exactly how much time how much energy, what was the changes in the tissue during ablation. And we can do it either focal ablation or continuous ablation by moving the transducer. This was recently presented in European Heart freedom Association and was later published an EP Europese. So when we show these type of images to physicians, they are pretty impressed with the trans morality with their parent homogeneity of the lesions, it's very clear where you've been bleeding and where you haven't. The company got very nice market traction we won first place the ICI cardiology conference in in Tel Aviv first place, out of 63 companies. So for us it was like winning the tennis in Wimbledon, few other competitions. And then in 2022, we won a grant from the European Union. And just recently we were selected for the 2023 MedTech Innovator cohort. It's very difficult to underestimate the market opportunity more than a million procedure per year more than 2 million procedure newly diagnosed patient every year. So there is no shortage in patient population there is a shortage and capacity to do effective procedures and a standalone system that can simplify and streamline that procedure can be very successful in this market. So right now, we are in our development phase, we are looking to complete the development and first in human study raising $7 million to complete those those tasks. We have about 50% already committed and looking for a lead investor to join the round. We have been able to leverage on the fact that we are developing a platform technology. We have a collaboration agreement with two other strategic companies, one in the neuro in the renal denervation space and the other in the lung tumor detection. Those agreements gives us cross licensing rights, external funding and in the future royalties once it to be commercialized. So the main message is that we are not a one trick pony company. It's where our main focus is atrial fibrillation, but it can be used for additional indications as well in the future. So to summarize, we are developing a platform technology will result platform technology for rapidly growing markets which our potential and clear unmet clinical need. Were very nice in promising preclinical data support from KOL market traction and believe we can develop the right solution for the right problems. Thank you