Jeff Vaitekunas Presents WaveClear at LSI USA ‘23

Transcription

Everybody, thanks. Hi, I'm Dr. Jeff Vaitekunas, the founder of WaveClear, a medical device company focused on a $1 billion a year market opportunity. We make our money Yeah, it is hard to use, isn't it? Oh, here we go. There we go. We make our money selling single patient use disposable kits to interventional radiologists and cardiac cardiovascular surgeons. Standard interventional radiology techniques are used for this procedures, these procedures. We have a reusable generator that is placed in the hospital. And then we have the disposable kits. We have patent protection on all of our technology. We're going after cardiac valve decalcification. So as people age their hearts get calcifications on the on the valves. And we're going to clean that off. And the way I came about this idea was on a predicate device of mine that we were using for peripheral vascular disease. It was a therapeutic ultrasonic device. On the left side there is a clog vein. We used our device in the vein cleared out the clog. But what was the amazing thing about it was on the right side hard to see on this, this graph, but this presentation, but what was amazing about it was the valves inside the vein were not damaged. So we were able to use our therapeutic ultrasonic energy, clear out the blood clot and still have Payton veins. And I said to myself, well, this technology is even better the heart of the material is. So if we work on calcifications and it doesn't hurt heart hurt the veins, the petals of the valve, we can clear the calcium off of the valve and basically have a curative procedure for for much heart disease 300,000 procedures a year, people have their valves replaced in their heart. The only treatment for this right now is the Tavor procedure where they're actually replacing the heart valve. But we're gonna go in is we're gonna go in and clear the calcium off the valve, make the valve patent patented and paid and again and not have to have that kind of a procedure 300,000 cases a year, we're going to sell our catheter for about $3,000. That's a $900 million a year market. The technology works through tissue selectivity of ultrasound, cavitation micro streaming macro motion, if you go to our website, you'll be able to see videos of these and get a lot more information. We have a very small team of people, but we have a very deep technology capability. I have been in the business for over 30 years, we have just our most recent hire was Jim Reese, he was the Sales Director for the angiogenic product, which is a peripheral vascular product. So he knows all the players and all the people in the market. The reason that's important is because we are launching our first product in May of next year. So May of next year is going to be going to be a 510 K approved product for peripheral vascular applications for like the predicate device. But we're really focused on the valve decalcification. So as a company, we had a series a of about 1.1 to $5 million. We use that to get to prototypes, proof of concept work. We are right now in the middle of a bridge loan that we're using to get to the launch of the first product in May. We've closed 825,000 on that I think we about have the right runway to get to the to the market with the device. But what we're here looking for is a series B investors that are going to help us do the clinical trial necessary for the cardiac valve decalcification. So the peripheral vascular stuff is just a 510 K pretty relatively simple to do. But the the clinical trial is going to be expensive. And so we're looking for that or we're wanting to talk to strategics as well who might be interested in this technology. By the way, shout out to Richard Fang from Honeywell like Venture Partners. He's our major investor and they are here at the meeting today and tomorrow, taking meetings for other companies looking to do the same thing we're doing. So the strategy is we're going to launch in May next year, we're going to have a product that uses is good for peripheral applications through a 510 K and it will be for peripheral arterial disease and deep vein thrombosis. That's great. But we're really focusing then on taking that product, putting it into human clinicals for the valve decalcification once we get that done and we can launch that product then we have a pipeline of products which we can look at pulmonary embolism whatever else we want to do. So heart valve calcification pulmonary embolism, breaking up plaque atherosclerosis, I mean there's there's no no lack of opportunity for this technology. It's just a matter of getting it out the door and getting the funding to do it. There's money to be made so AR kit, the disposable kit the COGS is about $370 We're going to sell it for 3000 for the peripheral application, no price set yet on the on the valve decalcification but that's a good good product. And then the generator. We propose to sell it at 10,000. But really we just want to place it in the hospital and and get it in place that people can use it. My contact information, I'm here to answer questions happy to happy to help and again looking for some series B investors and strategics. I want to talk about this product line.