Gabriele Niederauer 0:03
Well, thank you very much. I'm honored to be here. Today this my first time at the LSI conference and what an amazing event. And I'm even more excited to present to a live audience versus a computer. So Bluegrass Vascular Technologies is a commercial stage medical device company. We're located in San Antonio, Texas. We are focused on innovating, life saving access procedures for chronically occluded central veins. And 2019. We were recognized as a top 10 nephrology provider, largely for the lifelines that we have placed been able to place in dialysis patients. Last year, we were recognized as a showcase company for the global MedTech Innovator program. So the company was started in Kentucky. That's why we're called Bluegrass. The product was invented by an interventional cardiologist Dr. John girly. I joined the company in 2014, just after the first in human studies have been completed. But as you can see, in our timeline, we've been able to hit some key milestones over the last few years. Specifically, our FDA approval via Denovo in 2020. followed a year and a half later by getting a CMS code and we just closed on a $5 million convertible node, which adds up to about $22 million that we've raised to date. So what are we trying to solve? Well, placement of central venous catheters is the number one hospital procedure there are about 6 million catheters placed each year. The problem is with these long term catheters reside in the body, they cause the veins to react, creating thrombosis, and when that is left untreated, it results in chronically occluded veins or the obstructions that happen. And you can see the symptoms associated with central venous disease are quite impactful for the patients swelling, edema, migraines back that cerebral back pressure, very low quality of life. And this is important because we only have four central veins in our body. central venous catheters are typically placed on the right internal jugular, but when that vein gets occluded, physicians will simply go to the left. And so they end up burning up all of the central venous real estate that's important for providing this access. And so what we're trying to address is having a tool that can get access at that right internal jugular obstruction and preserving all of the other real estate for future clinical use. What is our market opportunity? Well, if you take the 1.3 million patients on a long term catheter 52% will have thrombosis. And what really we are looking at and targeting are the symptomatic venous occlusion, so it's about 213,000 patients a year. But the most critical patients are those that all central veins have been obliterated, and they're possibly on a femoral catheter, that's another 27,000 patients a year that really need our product to give them a lifeline. So that top tip of the iceberg is our initial target market. So based on the ASP that we have in Europe of 3900 in Europe and $5,595. In the US, our initial target market is about 750 million, with a total addressable market opportunity of 3.4 billion. The surface or inside out access system, which is featured here is our flagship product. You can see in the kit that we provide it has all of the components necessary to contest the procedure. It's a single sterile, use product with a 90% gross margin. The specialties that would use this product and have been using it are the interventional radiologists, vascular surgeons and interventional nephrologist. And as I mentioned, applications are largely dialysis. But we also are able to treat patients that depend on chemo or nutrition or pacing for their central axis. So our product is based on a simple approach of inserting a guide wire through the femoral vein. Over that guide wire, we insert our components we progress through the central vasculature to just above the clavicle. Our unique and patented technology then takes alignment with a target on the skin to advance a needle guide and it's through that needle guide that we advance a sharp needle wire and once that exits the body is through that needle wire that we're able to insert a catheter or other access device. So it's designed to be safe in that no sharp component is ever advanced until we're directing it away from the Heart and the lung. Mentioned earlier, we've already hit our key regulatory and reimbursement milestones CE mark was achieved in 2016. We've got Canadian approval, we're able to get our Denuvo clearance in February 2020. And then last fall, were able to get a new reimbursement code for our Inside Out procedure. We are protected by a number of patents and trademarks. And so we launched the product in Europe after we received our European approval. And so that has really served as the test ground because we've always known that US is the largest market. But as you can see, on this heat map, we've had almost every country in Europe use a product we have about 80 commercial accounts, the highest being in Germany, high success rate, and the procedure is done in 20 minutes, which saves significant time from what other physicians might try to attempt to get access in these patients. In the United States, we have 120 physicians that have already been trained. This is since our approval two years ago. And we are seeing now with the positive CMS decision last fall a significant uptick in interest, largely from interventional radiologists, which are very comfortable with this procedure. So physicians like Dr. storytel, in San Jose California who deal with complex vascular access on a daily basis, are establishing themselves as centers of excellence for our product. In 2021, our sales in US and Europe were about 600,000. But I wanted to show here for you the uptake that we've had quarter over quarter in us certainly driven by the positive CMS decision. And based on this adoption rate, we are forecasting sales of 70 million revenue of 70 million year five largely by the US portion of of our revenue. It's really important with novel products like ours, that there's data and evidence and we now have collected data in over 200 cases, which has resulted in 12 peer reviewed publications. What's important here is that this is evidence not only in our own hands, but also evidence from Independence, multicenter studies. And what they have echoed in our hands is that there have been no device related adverse events, the product performs very safely and effectively. So demonstrating the product, the robust performance of the product. I'm very honored to have an amazing team that I work with, with deep experience in the different specialties. I am a biomedical engineer, I joined the company seven and a half years ago, I focused on taking innovative products and bringing them to market. The previous companies I've been involved with have all been acquired by public companies. And so we're very excited about the opportunity that we have for our company. So in summary, with all of the key regulatory approvals and reimbursement at hand, we've significantly de risked this technology. We are near cashflow positive, with only having spent about $20 million. And we're really well poised to take this exciting product where there is no competition. There's no other product like ours, and penetrate the US and European market with our goal of hitting 7 million in revenue in year five. So thank you for your attention. I'll be glad to answer any questions in the breakout session.
LSI Europe '23 in Barcelona
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