John Ashley Presents Durvena at LSI USA ‘23

Transcription

John Ashley  0:05  

Hey, good morning. Thanks everybody for your time getting up early. And joining us. My name is John Ashley, the CEO of DurVena where we have a brand new innovative vein strengthening therapy to reduce post surgical failures. So the problem is that a million patients in the US every year have surgery to use one of their veins as an arterial pathway. These are cabbage surgeries coronary artery bypass grafting, peripheral artery disease and AV fistula. But as this chart shows, these vein grafts have a high failure rate. Things aren't intended to carry arterial blood flow, they dilate. They react to it by growing a lot of tissue and they close themselves off from the inside down. And when they close off the reintervention is very expensive and risky. Our solution is photochemical tissue passivation. This is a brand new modality that was developed at the Wellman center for photo medicine that's also brought such innovative technologies such as fractional lasers and cold school sculpting. What we do is we put a photo initiator on the outside of the vein. We hit it with light that activates it and it creates covalent cross links in the collagen matrix matrix, which are permanent and strengthen it, turning the vein into an artery. This is what our technology looks like we use roseburn gall dye it's been used in medicine for decades, put it on the outside of the vein, put that vein in a single use disposable vein carrier, that's our razor blade. You plug that into the light chamber, our razor, do a five minute treatment at crosslinks the collagen and you go back to the surgery. This is what our published preclinical data looks like the first image is a vein three months after implantation. You can see how dilated and twisted it is versus the other photo, our treated vein nice and smooth. The chart at the bottom shows what the mechanical properties are, we increase the elastic modulus of the vein 18 fold, that's about a five times increase in the stiffness, you can see our treated vein is almost the same stiffness of an artery of the same lumen diameter. What's more important is what happens on the inside. I told you earlier that these veins grow lots of tissue it's called intimal hyperplasia that closes the vein off. This is the three month published peer reviewed data. You can see the much smaller lumen in the control vein. Compared to our treated vein we've shown we reduce intimal hyperplasia go up by 70%. We also reduce the medial growth the middle layer in the vein. These This is where we've published our preclinical studies all in top peer reviewed journals. Importantly, in cabbage, our process maintains the current surgical workflow. The first thing that happens is the vein gets harvested endoscopically as in the first photograph, once that vein is harvested, and the side branches are ligated, it just sits in a cup of heparinized blood until the surgeon is ready to start sewing it onto the heart. During that time, the surgical staff will do our treatment we won't take any time from the surgeon maintain the current workflow. This is our worldwide portfolio of patents over 18. I mean over 13 and many more pending. All told we see this as over a $6 billion market between these different verticals, with very modest HSPs and a very high 90 95% gross margin. Here's our founding team. I've been in the medical device industry for 30 years, seven startups that have exited two of those IPOs have returned over one and a quarter billion dollars to investors today. My co-founder Jay Austin is the head of reconstructive and plastic surgery at MGH. He has co founded two other medical device companies, one of which exited in 2021 and the other one launched its first product last year, Mike McCormick co founded those companies with him. And Bobby Redman, a sociate professor at Harvard is the world's foremost authority on the interaction of tissue and light. We've got a very strong advisory board to both on the business side and clinical top cardiothoracic surgeons throughout the company in the country, as well as cardiology imaging specialists to look at how are treated veins compared to control veins. We've had to pre subs already with the FDA. We've got a third meeting with them scheduled educating them on this technology and and laying out our pathway to the market. We've raised $6 million to date and convertible notes. We're currently raising more to fund the company through our first and man Oh US study at which time with that clinical data will raise a Series A to do our US studies. I'd like to clewd include this quote from our top individual investor Don milder. He's currently the chairman of the board of an army medical right down here in southern In California, he's the former Co Founder and Managing Partner of versand Ventures. So he has five decades in the medical device industry. This is how we're going to use the funds pretty evenly between r&d, preclinical, and clinical studies. And here's our timeline. To complete all our clinical trials, get FDA clearance and either exit or raise a series B. There are no current competitors on the market. There has been past attempts to address this huge unmet clinical need in the form of external stents, chemical treatments, or artificial graphs. To date, no artificial grass stays open very long when it gets below a very large diameter. There's many other products and development including Mr. Villafana right here who's going to talk later, trying to develop bio graphs to address this problem. comparables in this market are impossible to pinpoint because nobody's addressed this problem before. But in the cardiovascular market in general, everyone knows it's the most dynamic m&a market with very high returns. And often these companies are acquired very early with just preliminary clinical data or some regulatory approval. So in summary, DurVena has a novel technology to address multiple markets. We've got a strong patent portfolio, great management, and extensive peer reviewed published data. We're currently raising money that'll get us to this huge inflection point of clinical efficacy. Please come visit me upstairs in the innovator pavilion where I'll show you our products. Thank you so much.