Murali Srivathsa, Akura Medical - Innovative Thrombectomy System | LSI USA '25

Murali Srivathsa  0:04  
Good afternoon. And Akura medical is a clinical Stage Company, and I'm delighted to be here to talk about our differentiated and intelligent thrombectomy system. I'm Murali Srivathsa. I'm the CEO of Accura medical. Many of you have heard of venous thromboembolism. It affects about 900,000 patients every year in the US. Consists of two main conditions, pulmonary embolism and deep vein thrombosis, and results in about 960 200,000 deaths every year per the CEC, CDC, it's a large addressable market in the US, about 280,000 patients with pulmonary embolism can be addressed with mechanical thrombectomy. Again, it's one of the newer technologies that has evolved in the last 10 years or so. And on the defense, thrombosis side, about 430,000 patients can be addressed using this technology. As you will see on the slide, only about 15% of the pulmonary embolism patients get access to this technology. Again, it is growing every year. And on the defense, thrombosis side, about 20% of the patients are getting access to this technology internationally. It is still in the early stages as clinical approvals and reimbursement catch up in those markets, and there's a huge untapped market in Europe, Asia and the Middle East. So while the industry has made significant strides, you are now it's roughly about a little over a billion dollars in the US every year. There are significant challenges, as indicated by our market research. The first thing is, how do you prevent the catheter from clogging as you try to retrieve clots that are complex or are large in volume, systems clog easily, and you're trying to prevent clogging with the system. The second thing is, how do you navigate to the location of the clot in tortuous anatomy? And then, as the physician is conducting the case, how do you provide high quality interoperative feedback in a timely manner so that they are able to correlate clot removal in the patient with patient improvement in patient biomarkers? So how does Katana address these needs, to address the issue of clogging? We use high velocity jets, saline jets, that break up the clot and are aspirated out. We have a low profile, steerable system that is a single pass system that allows you to get to the location of the clot so that it can be removed, and then our console is able to provide feedback to the physician in terms of blood removal, in terms of clot engagement, and in terms of patient hemodynamic pressure, so that the physician can know what is the impact of clot removal. On the next slide, I will show how these things come together. So the system is the katana system, and again, a CT scan is usually taken at the end, at the beginning of every case, the system is delivered to the target location as a 16 French sheet there, delivered over a wire using a dilator. Once you get near, near the clot, you deliver the funnel catheter, which is a 12 French catheter, to the site. Shoot some contrast to the system, and then you you you assess clot engagement. Once the clot has been engaged, you start breaking up the clot. You can see the clot is being broken up at the base of the funnel with the help of high speed high velocity saline jets, they're broken up into small pieces and then aspirated out of the body. So this is allows us to have a lower profile system and still have the effectiveness of larger bore systems. The system is steerable, so you can steer to the next clot location. Again, shoot a little bit of contrast to make sure you're engaged with the clot. Capture the clot, break it up with the help of the saline jets, and then clear the clot. So this single pass system allows you to complete the case in a predictable manner. So one of the elements of. System. At the bottom you will see the 16 French steerable sheath. It's a bi directional low sheath with a low profile sheath catheter system. To the right you will see the activation button on the catheter so the physician can control aspiration and then aspiration plus jetting on you see the console there. It's a it provides intraoperative feedback at the distal end of the product, you see the expandable funnel at the end of the catheter, you see the integrated sensors on the sheet, so we have a fiber optic pressure sensor that is providing continuous hemodynamic monitoring to supplement the information being made available to the physician. So where are we? In terms of clinical cases, we did our first in human in 2023 in the Republic of Georgia. We treated five patients. The results from this study were presented as a veins late breaker in 2023 in 24 we expanded our clinical work to Brazil and Dominican Republic at a total of three sites, we treated 18 patients in 2024 so that got us to 23 interestingly, nine of these cases were supported remotely, and two of them were conducted by a US Kol. Based on the data presented at the veins conference last year, the reduction of RV LV ratio was about 35% in 14 patients, and there were no device related adverse events. In November, we got approval for our pivotal IDE to treat AI pulmonary embolism patients in the US. The study was for up to 118 patients, and that's trial has started earlier this year be our first patient was enrolled at the Tri star Centennial Medical Center. We are also expanding to Europe. Our first site in Austria has been activated, and we are continuing to add us patients and enrolling patients. US sites and enrolling patients. We are in located in the heart of Silicon Valley, right next to Netflix in Los Gatos, and we have our own 22,000 square foot facility. It's vertically integrated. We manufacture all of the disposables and the consoles at our facility. We have a clean room there, 3700 square feet, and then, based on some of the metrics from last year 2024 we had a 98% yield on disposables, 100% yield on consoles. We are already at having good margins, 80% margins, and we can expand the facility to supply for up to 10,000 patients every year. This is a very experienced leadership team with an average experience of about 25 years at both big and small companies, and this, this is the group that is driving the company forward. So we are, we are here in the in the at the beginning of our CDC raise, fund raise. So what, what will the investors in CDC see over, over the time period, multiple regulatory approvals, our first B, te, 510, K clearance to treat venous thromboembolism. Once we complete the study, we will also submit for that that will give us the approval to go after the pulmonary embolism market. We will complete enrollment in our clinical study, share the results on the podium appropriately work on next generation cloud engagement and cloud clear algorithms show the value of the supplementary hemodynamic information provided by our system, and then start with early commercialization. So all of these things our goal is to complete in the second half of this next year. So this will CDC will get us through that time period. And I mentioned already that the gross margins are pretty good. So overall, we have designed an intelligent thrombectomy system. Clinical stage company, 28 patients treated to date, we have good cogs, and we're supported by some of the top KOLs in the world. This is a portfolio company of shifa Med, with five cardiovascular and two ophthalmology and software company. We have raised $60 million so far, and the next round of financing is for the $35 million Series C, which will get. Us to early commercialization. Thank you. Applause.