Leo Mavely Presents Advamedica at LSI USA '23

Transcription

Leo Mavely  0:05  

Good evening, everyone. I know they am the person standing between you and cocktails. So I take the responsibility quite seriously. I'll be brief. We are a hemostat company, we are in Dubai materials. Our claim to fame was creating products for military to help them control life threatening bleeding. We've been quite successful at that. We have multiple devices in the market right now in our 50 countries. We have FDA clearances, CE mark all of that. We primarily started with defense work through armed forces around the globe, helping them have something like this, this is a life saving hemostatic gauze that they carry in their field kits. And they apply when there's life threatening bleeding. And we we sell hundreds of 1000s of these products to major Armed Forces globally. And then we took this military technology to hospital and we started implementing that for vascular closure. And their latest foray for us is surgeries in vascular closure. We are the market leader in multiple countries. This last year, we have done about 200,000 closures and femoral and radial arterial closures, completely replacing the need for mechanical closure devices. But today I'm here to talk about our recent innovation that's going for surgery. And we also have a division that goes into advanced wound care from the same platform, which is again a CE mark device currently undergoing FDA review, we have raised over $20 million till date, we do roughly between four to 5 million in annual revenues, with profit, operationally profitable in multiple regions, tracking EBITDA profitability by next year. So our range is called axis that it's a five year shelf life by Mitchell based devices unclassified in the US cluster in Europe, approved in about 45 countries, we have a whole range, we're probably the only company globally having a full range of hemostatic devices, right from pre hospital procedures and now intraoperative. So, you know, surgeons obviously, need better hemostats for the reason that they need to reduce the surgery time before the patient needs to go into longer anesthesia. And there's a cost associated with the surgical time. You know, if you prolong that time, there's a lot of cost associated with that all are in search of something better. And that's where we developed a exergy. This is a device under development for last four years. I'm glad to announce that we just got the FDA clearance like three weeks back. This is the first clearance for a biomaterial in the space by FDA, there's a new category that has been created called pod category, completely negating the need for pre clinical trials to create surgical hemostasis. It's a new category called temporary hemostasis. What it means is, FDA recognizes that a lot of these hemostats in the market are although permanent, doesn't provide immediate bleeding control. And that's where we brought in military technology to surgical table where you can have instant bleeding control in matter of seconds and not in minutes. And this is temporary so you can continue with the surgery and then remove it using normal saline irrigation and nothing left behind. And obviously takes much more rigor for FDA to clear that up but it's still a 510K not a PMA product. So we got the clearance. Ours is a third device in the category to be ever cleared. The first device that got cleared, again came from US army called kick clot got acquired by Teleflex for half a billion dollar. The only three devices cleared in the market so far ours is a third one. So we are very proud that we got the clearance. It took about a year and a half with FDA. In the interest of time, I'll skip to the details of the device. It looks pretty much like any other hemostat but it comes embedded with a radiopaque thread, a surgical fabric and the beauty of the whole thing is it's still 100% active ingredient patch which works on a catatonic property. So it's pretty it doesn't have any blood components. It's pretty clean to use without any complications. It's the first biomaterial base hemostatic patch ever cleared by FDA in this indication. It goes against devices from Johnson Johnson Baxter which are in the average prices of about $500 or above this would be somewhere in between 20 to two $50 product. So definitely a huge cost advantage when you use them in multiple surgeries. It works on this small video how what kind of bleedings we're talking what we're talking with severe bleeding wounds, which are arterial in nature, which has a high spot, difficult to control with a manual compression, you can use sealants on that because it will just fly off. And that's where, you know the patch, which we have developed works, it works on something as simple as something what they call as catatonic property, which means it carries a charge, blood carries a negative charge, and they create a bond, which is quite instant. And that's reversible. So that, you know, surgeons can literally take it out post surgery and then you know, close the wound. And as you can see, with like minimal compression at the bottom, you know, 30 seconds to 45 seconds, it completely controls the bleed and remains in position for as long as you can keep it for 24 hours. And it doesn't dislodge the clot. So it's used for damage control surgeries, it can be used in hepatic recessions, even going forward for cardiac procedures. So long possibilities of versus devices can be used. Again, in the interest of time, I'll move on. These videos are available for anyone who would like to see how it works. So we operate in the traditional wound care to advance wound care market. We have products that go from pre hospital to procedures to intraoperative. In both the hemostatic side and the advanced wound care side, all the devices that we work with are either FDA cleared or CE marked, so they are already cleared and available in the market. Same thing just talked about going against Baxter's and Johnson Johnson of the world, we have a large team, we have our own vertically integrated manufacturing, where we manufacture these in millions. We have folks from you know, ex-j&j and expertise from the subject matter experts from the field working with us. We work with Howard & Brighams. We just finished a pivotal study on this biomaterial. Literally going deep in finding out the science and the mechanism of action, which has never been elucidated. We found the receptors that are responsible for the clotting action. And it's currently under Publication right now. We have a large suite of parents over 21 granted in multiple geographies, many pending right now. And full suit of parents that protects the material to utility and the design of it. So yeah, so we raised over 21 million fully deployed, we still have, you know, good runway based on our revenues that are coming in. We are raising 15 million series C round as a next step. And we also have strategic interest on multiple of our assets. We are open to conversations with companies who are interested to partner with us in market entry in the US or in other markets. We are very strong in European market. We have a team over there in in Europe, with multiple partnerships. So happy to talk and you know if you're interested, ping me up. Thank you