PECA Labs | Doug Bernstein, CEO

(Transcription)

Doug Bernstein  0:04  

Thanks, everybody. My name is Doug Bernstein. I'm co founder and CEO of PECA labs. We are a commercial stage developer of polymeric, heart valves and vascular grafts. So we have two core patented material technologies that together form the platform for our suite of four disruptive products. And those have a total of about $9 billion of addressable market in the US, all of them are really addressing the same clear unmet need, which is that biologic heart valves and current vascular grafts have insufficient longevity. Our solutions have been largely proven out, we've already received our first FDA and CE mark clearances 1000 Human implants of our first device, and highly differentiated solutions. So we're talking about polymeric, Valve conduits, polymeric valves, non pharma, anti thrombogenicity, and vascular grafts. really significant market potential when you put all that together. Broad IP coverage, we have six issued US patents already, with a number of additional patent applications covering every aspect of our devices. Strong early traction with our first device, which we targeted towards the pediatric cardiac surgery market, eight of the top pediatric heart surgery centers in the country already use our device about 20 of the top 30. And between our four products, we have a quick path to growth with regulatory milestones for all of our products coming up over the next 18 months, and a top notch team to bring it there. So this is sort of the way our product suite lays out. Right, so we have our two core patented technologies, our expandable graph technology that allows for pre implant customization, as well as post implant expansion. And then we have our patented ultra low thrombosis membrane technology, which provides material that's more clot resistant than heparin bonding on a polymeric material, but it's also strong enough and flexible enough to be able to be used as valve leaflets. Together, they form our product suite, which goes with our strategy of first targeting niche pediatric markets, where we can get quicker market entry, clinical proof and significant growth, but can also use this technology to prove out towards the much larger adult market so we can address so our four products are x craft, an expandable vascular graft, which is already FDA and CE mark cleared. And then we use that same conduit that expandable graph technology integrate that with a valve to make our masa valve our polymeric valved conduit for pulmonary valve reconstruction, again in pediatrics proving out our valve technology. This one's already received its ID clearance from FDA actually just a week ago. So we're about to start clinical trials on that. combine those together if you use our ultra low thrombosis materials, the luminal surface of the graft, you get our Okapi ultra ultra low thrombosis, vascular graft for peripheral vascular dialysis access. And finally, because our valve material is able to be applied to any position, we're also developing that into a transcatheter aortic valve for the aftermarket. So this is how it all lays out with our clinical milestones over the next 18 months. So right now X graft already on the market over 1000 Human implants of those we've already seen successful dilations for for neonates and children and about 50. So it's well clinically proven already. Massive Alba first valve which is going to be getting of the market has already received its investigational device exemption clear from FDA. So that's already able to be going to humans, it's going to start clinical trials in the next couple of months. Our low thrombosis vascular graph, which is going to be the first for the adult market, that's going to be we're expecting to get that FDA cleared around the beginning of next year. And then our transcatheter valve looking at that first and man by the end of 2023. So not too much time here, I'm going to quickly go through a little bit more of our four products. But really I encourage anyone who is interested in this type of field to come and talk to me after because the four products in nine minutes, there's just not that much time. So x graphed. Like I mentioned before, pull America expandable vascular graph. So targeted first towards the pediatric market about a $50 million market its niche but as a great need. So this allows for pre implant customization for complex anatomies, but also critically post implant expansion. So if you plant this in a neonatal and infant and they outgrow it, you'd be able to actually go in with a minimally invasive procedure and be able to dilate that provide growth potential without worrying about any of the uncertainties of tissue engineering or anything like that. That's still years away from the market. So this is on the market now. 1000 Plus human implants already well clinically proven. We take that same conduit integrate our proprietary polymeric valve technology to form the masa valve, and this is targeted towards the pediatric pulmonary valve reconstruction market. So right now in that market, there's only biologic options available. Those tend to fail very quickly, due to immune response calcification. We can solve those issues with our pulmonary valve leaflets, but we can also solve the growth potential issue by using our expandable graph technology, so you get both those benefits in one. So this is about to start clinical trials, about $100 million market in the US, but one that we expect to be able to capture to a large extent, because we can offer such a significant benefit. Using those same polymeric valve leaflets, we're going to prove out in the pediatric market, we can also integrate that into a transcatheter aortic valve setup. That's what we're developing first. But realistically, we could develop that into any valve position. Our polymeric valve leaflets are strong enough and flexible enough to match the hydrodynamics of biologic tissue. But we expect to have much greater longevity because of their bio inertness. And then  finally, we have our ultra low thrombosis vascular graft. So this is where we've taken our proprietary material that we developed for valve leaflets, but it's, it's able to be anti thrombogenic enough that actually outperforms heparin bonding on PTFE. So you can see in the picture of the bottom of the screen of where we have standard PTFE heparin bonded PTFE, and then the PICO copy graft, significant difference in the level of thrombosis when you expose those to blood. So when when Gore came out with their probate and vascular graph that has the heparin bonding that quickly took over the market, they sell about 600,000 units in the first eight years on the market. So really significant market opportunity there, if you can show greater anti thrombogenicity. We believe we can do that not only in the short term, but also in the long term, because our anti thrombogenicity is an inherent material property, and not a farm, not a pharmaceutical coating that's going to wear off over time. So this one, we're expecting to be FDA cleared by, by about the beginning of 2023. All these are covered under broad IP. So we have six issued patents that cover every aspect of our different technologies expires out in the 2030s, worldwide coverage and more applications on the way.And this all adds up to our sort of stackable revenue projections, right where we have the extra effort on the market today that can already get us a good ROI. Add in the master valve, it's about being in clinical trials. And that just grows from there. And once you add in those adult technologies, that's where we get to about 150 million revenue potential and in the next five years. So this whole how it all lays out right with our clinical pathway leading to our fundraising.So x graphed on the market now masa valve, it cleared about to go into clinical trials. This is where we're raising about three and a half million dollars today, we could close this now, we're really only leaving it open for the next couple of months. In case there's any new investors that we want to take in that adds significant strategic value. But our current investors have already offered up enough to close this to get us through the okapi clearance, and then getting the IDE clearance for our transcatheter aortic valve by the end of 2023. So second half of 2023 is when we're targeting a series b about seven to $10 million right now. And so that'll be another opportunity to come in. So the end of the day, that's who we are commercial stage developer of pulmonary heart valves and vascular grafts. All of these address clear unmet need proven solutions with highly differentiated technologies that have broad IP coverage, addressing a significant market potential, strong early traction, and a quick path to growth over the next 18 months. So if you're interested in want to learn more, I know not too much time to go through the details of how all this works. So please come and talk to me after my name is Doug Bernstein, a co founder and CEO. Thank you