Ran Sela Presents Healium Medical at LSI USA '23

Transcription

Ran Sela  0:00  

Hi everyone, I'm Ran Sela, co founder and CEO of Healium Medical. We are developing ultrasound ablation technology platform for treatment of atrial fibrillation. Okay. I'm sorry, will do okay. Okay, so a tribulation is the most common cardiac arrhythmia, it's affecting millions worldwide. When you have atrial fibrillation, electrical triggers that are originating around the pulmonary veins are causing the heart to fibrillate, leading to blood clot formation that can travel to your brain and lead to a stroke. So if you have a if your stroke race is five times greater Cornerstone treatments called catheter ablation, in which legions of scars are being created around the four pulmonary veins to prevent from those electrical triggers to get into your heart and fibrillation because the defibrillator. But to be successful in this procedure, you have to create a fully circular region, no gaps, make sure that it's permanent and full thickness. If one of these criterias are not met, most probably the patient will be back to a second procedure. And in fact, we see that up to 40% of patient will require a second procedure. And this is because of limitation of existing technologies. There are different types of technologies that differ from one another, but they do have the same exact limitation in common. The first limitation that all of them require tissue contact with a beating heart, that's not trivial to do. And if you don't have good contact, you're going to have no lesion. Secondly, they they tend to leave gaps within lesion points. And that's because the pulmonary veins have different shapes, and it's very difficult to create your confidential lesion. Third of all, none of them is providing any tissue thickness measurements or lesion monitoring. So physician base, physician blade based on experience. Our solution is different. Our solution is based on ultrasound technology, and it consists of four main components. We have the ultrasound console, the procedure software, the transient transducer motor unit, and the ablation catheter. So the way the procedure goes is that you insert a catheter over fluoroscopy. If overflows copy over the wire, you inflate the balloon when you get to the point that you'd like. the motor unit pulls the transducer and starts rotating it to get the two dimensional images, the longitudinal and the cross section. And based on that information, we can create a 3d model. Once we have that 3d model, we can rotate the transducer to create many ablation points where at each point we monitor the changes in the tissue as we ablate to provide insight of the quality of the treatment. So when physicians are using our technology or would use our technology, they get few main benefits. First of all, they don't need to worry about contact today they have to make contact with our technology, no contact is needed. They can can create continuous solution line by rotating the transducer and get real time vision monitoring all with a single tool. We've done many numerical simulation to evaluate the size and shape of lesions that we receive either continuous or point by point and we see through in vivo animal studies that by now we have pretty good agreement between the numerical model and the actual lesion that we receive. The setup that we have developed consists of an X Y Z system where we place our cursor, we move it to a different location within that matrix. And then we can receive many many ablation points and then characterize this the exact size and shape. What can be appreciated from those images is the very directionality of ultrasound ablation, so you only ablate in the direction that you face. When we show these type of images to physicians, they are usually pretty impressed with the homogeneity and continuity of the lesion. You can see that it's very transmural and we validate it through histopathology to make sure that it's also necrotic meaning that it's permanent. We have received pretty nice market traction by many multiple competition. The first one was the ICI 2019 It's a very prestigious Cardiology meeting, we won first place of the out of 63 cardiology companies. So for us it's like winning the Wimbledon so it was very exciting. We were nominated at the shortlist for the final innovation competition, the European hardware Game Association back in 2020. We're nominated were selected as one of the top 10 Presenting companies to 2021 and recently receive a European grant of 2.5 million euro non diluted and another allocation of 10.25 in matching funding. This is very important to potential impact faster because it means that we can match up to 20 point 25 million euros of your investment. The way we'd like to the way we would like to differentiate ourselves from our competitors is that we are the only company using noncontact ablation plus imaging. All of the other companies are using contact based solution and provide no imaging. It's very difficult to underestimate the size of the AF ablation market space. It's a very large market but still rapidly growing in double digits. Because it has constant growth drivers. There are more than a million procedure per year with more than 2 million people diagnosed every year, but still a very small patient of symptomatic patient if if undergone that procedure. And together with the many patients that need to have a second procedure, which it creates a very large market opportunity, especially for new technologies with simplified procedure flow. So we have completed our technological feasibility and technological development, we are now in the product development phase, we are raising $7 million to complete a product development and first in human study that we plan to start in q1 2025. Now in a way, we are developing a platform technology, and we are able to extend our reach through partnerships. So we have one partnership with a company called The Venus metric, where we develop using our technology to develop a solution for renal artery degeneration. That's for hypertension indication. And another licensing argument that we have is with a company called bronchus, where we equip their solution their delivery system with our imaging to treat lung cancer, peripheral lung cancer tumors. Those licensing agreement provide us non dilutive funding they provide us provide us with cross licensing rights, meaning that we can use the technologies we developed through those partnerships for anything else, as long as we are not competing in those indications. And in the future. We'll also expect to receive royalty from commercial efforts of those companies. So as mentioned, we look we are focused our primary focus is on trial tribulation, but our bigger vision is bigger vision is platform technology for multiple indication in chronic condition with clear unmet clinical need in your modulation space, pulmonary space and structural heart. So in summary, we are developing a platform technology for large markets with clear unmet clinical need. We have very nice results from preclinical studies, very nice subtraction from KOL in competition that we want, and we believe that we are developing the the right products for the right problems. And if anybody would like to have more information, I'll be happy to talk to you after this presentation. Thank you very much.