VenoStent | Tim Boire, CEO

(Transciption)

Tim Boire  0:04  

Hello, everyone. So I'm I'm Tim Boire. I'm the CEO of VenoStent developing these tunable bioabsorbable smart polymer apps to fundamentally transform fit transform vascular surgery. There are over 5 million vascular surgeries that use veins as replacement arteries. Because veins are not built like arteries half of these surgeries fail, drastically increasing mortality and impairing quality life. Venostent saves lives and health care dollars with a bioabsorbable rap applied during surgery to help veins become like arteries so they don't fail. We're raising a $20 million series a to scale our tissue engineering company over the next 36 months and get FDA approval for our beachhead haemodialysis application. We're addressing a 20 billion plus global addressable addressable market bottoms up. That's first starting with haemodialysis then for bypass grafting very poor standard of care. We meaningfully direct our technology through an initial feasibility study and 20 haemodialysis patients doing showing drastic improvements over standard of care. It's a well vetted active space with recent IPOs and acquisitions with technologies that actually don't even improve clinical outcomes. We're capital efficient management team that's built a high functioning team. With clinical domain experts backing us. And we're starting with haemodialysis, where kidney disease patients basically they don't have they have failed kidneys, they can no longer rely on their kidneys to filter out these toxins in their blood. So they need an external filter via dialysis to remove those toxins. And the current gold standard is is a native artery vein connection created in your arm for these dialysis treatments. And unfortunately, these are terribly officials, these ABS have a very high failure rate as the gold standard even a 60% one year failure rates. So this impairs quality and length of life for patients. But it also leads to significant cost burden on our healthcare system. It's cost $24,000 Every time this surgery fails direct costs and Medicare to our taxpayers translates to about $3 billion in annual costs to our Medicare system. So we've shown some very vast improvements over the current standard of care. In our initial feasibility study involving 20 haemodialysis patients. So we've shown improvements across the board and most notably an 8x reduction in the maturation failure. So 40% of time they do this artery being connection in the arm to to create this our teammates fistula so they can do these dialysis treatments through the arm. But 40% of time, the veins are never used for dialysis. We've shown we showed only a 5% maturation failure here. And so this would be translated the general population, even if it was half as good as this could save 1000s of lives and billions of healthcare dollars annually. Why these fail is because the vein is not built like an artery. So basically, you have an over deformation that occurs when you hook up a vein to an artery, it just over expands. There's a lot of violence, pulsation, that leads to an injury to the inner protective endothelial lining of the vessel, which then leads to this cascade of proliferation of smooth muscle cells inwards, causing the seclusion and lack of blood flow, where you need to intervene or just abandon the site. And there are only so many sites so you're just essentially having to rely on a central line catheter to sustain life. So what we do is we apply this rap at the time of surgery, this compliant artery mimetic wrap to help the vein basically more naturally adapt to this environment. So you don't have this type of response. And you can use the vein for dialysis or have and have better long term patency outcomes. So you can see this conformal vascular wrap comprised of bioabsorbable smart polymers applied around the artery vein connection in the arm of dialysis patients. It's providing this mechanical support to help the vein first behave like an artery and then become like an artery. So tissue engineering approach, we've, we've optimized our design so that we're promoting outward remodeling to prevent this inward remodeling process that causes this collapse in these failures. We also have an angulation effects. It has hemodynamic impacts, to basically improve the patency through the entire vascular circuit of the patient. We're a bioabsorbable solution. We've tuned our material properties or thermal mechanical degradation properties to be optimal for this application. And it's a conforming fit To each patient where these are complex geometries that's important for effect more effective mechanical support and outward remodeling of the vein. It's also simple to deploy, it's only adding a minute or two to the current workflow of the surgeon. In our initial feasibility study, we saw no device related adverse events. Through nine months of the study, we shown superior patency to the standard of care. And I mentioned that 8x reduction and maturation failure, so more of the veins are being used for dialysis. Not only that 90% of our patients did not require any intervention to use the AVF consistently for dialysis. Whereas in the United States, you see only a third of patients that reach a point of maturation without needing an intervention, which really has important long term implications for the functional use of the vein, consistently and durably. Over time, it's also being used quickly. So we see only two months to the point of AVF use compared to what you see where the average patient in the United States has to wait six months before they can use the vein for dialysis. So we're starting with our $3 billion dollar beachhead in hemodialysis access. But also we have ongoing programs in bypass grafting. And in a disease large animal model at 90 days, we showed a significant reduction in new into well maturation, the primary culprit of these failures is in order modeling, as well as a reduction in stenosis. So we have a great competitive position to our competitors in the sense that we're providing better clinical outcomes, then some very scientifically interesting approach like hemocyte, these decellularized tissue engineered blood vessels, but also providing the clinical benefit. And then, you know, compared to laminate our closest competitor in development, they have sort of a somewhat similar mode of action in the mechanical support component of this, but it's a long term, metal cage, long term implant metal cage around the aVF, which could have long term complication issues. So we're able to obviate all those issues, skin erosion infection, you know, any pain caused by long term implants, ability to remove or intervene with ease, and it's also the user preference from both the patient and the surgeon to use a bioabsorbable solution that goes away after it's no longer needed in the body. We also have the ability for superior performance. So we are doing mimetic support and conforming fit should provide this more effective mechanical support and outrigger modeling for improved for improved maturation and patency. We anticipate being on the market in q1 of 2025 for haemodialysis application and raising the this $20 million series A for this US pivotal trial to fund that and get FDA approval and haemodialysis axis also to scale our manufacturing capacity and expand our team. We're currently nine full time. We recently hired a VP of Operations who has over two decades of experience in class two and class three devices, both pre FDA post FDA. So help in has has multiple successful exits of startups. To help us get to the finish line here. We also have a great board of directors consisting of current investors. And we have great clinical Scientific Advisory Board that helped to inform all the initial feasibility, clinical trial endpoints. These are some of these kale wells in Nephrology and vascular surgery, actually, right, the guidelines for how to do hemodialysis access trials, and how you define these endpoints. And we'll continue to work with them as we move towards our pivotal trial which we're planning to initiate in about 10 months. So we have great clinical partners or sorry, great other partners, funding partners, creative ventures, deep tech VC, the Bay Area IDG Capital Partners in we did Y Combinator in 2020. We also won the redesign dialysis, kidney X Prize in 2020. We're one of six nationally recognized projects by the Department of Health and Human Services in the American Society of Nephrology as a very promising solution to transform the care of kidney disease patients. Thank you very much