Chip Appelbaum, Novian Health - Laser-Based System for Tumor Treatment | LSI USA '24

Chip Appelbaum  0:04  
Good afternoon. I'd like to thank LSI for having me here today. And I like to thank all of you for your time. I'm Chip Appelbaum, President, CEO of Novian Health, and here to talk to you about how we plan to transform the how breast cancer is treated, and hopefully get your interest in it. We've developed a laser based system that destroys tumors. The first application is breast cancer breast tumors. And we're at a pretty exciting time, we're actually ready to go in Europe, we're actually approved in Europe should be signing our first distributor agreement within the next few weeks, which means that we'll actually learn what revenue means over the next few months. In the US, FDA actually switched us from a PMA to a 510 K path. That trial that pivotal confirmatory trial, it's the same design as our previous one is what FDA asked for. It should be completed in 18 months, and actually, we treated the fifth patient yesterday at UCSD. So things are moving. And one of the reasons I'm here is we're raising a round of convertible debt, we're looking for six to 10, we've closed on a little over two and a half another two that we're about to close on in the next couple of weeks, but could use some more help there. So let's take a step back and think about breast cancer. It's a life changing diagnosis, it means surgery. lumpectomy is the most common type of surgery, she's going to the O R cuttings involved, everyone has some level of scarring a third enough to justify reconstruction surgery, it's a week or more before she feels like herself. But the real sad part quarter to half of those women have to go back and do it again. Because they have positive margins. My own mom went through this and she was one of those that had positive margins and had to go back for a second surgery, which actually ends up with higher recurrence rates ends up with significantly more trauma. This is what we're changing, instead of going to an O R, you're gonna go to a procedure room where the biopsy was done all under local anesthesia, going in with a needle instead of a knife hitting that tumor till it's dead, far higher efficacy than surgery to get that tumor in a single pass, closing with a bandage instead of sutures. And you can get off the table and go right back to what you were doing. It also the payers will love it too, because we dropped the cost roughly in half. It really is about improving outcomes, lowering costs with a vastly superior patient experience. And it doesn't take too many degrees of separation to know someone who's had an impact from breast cancer. We're right now focused on the US in Europe. And when you look at those lumpectomies that are being done yearly that could be done with our laser, it's over a million procedures. Now this is a razor razor blade model, we expect the average ASP of the disposable kit containing the sterile materials for the procedure to go for around 2000 to 2400. So in US and Europe, that translates to a $2 billion market with the rest of the world, which is the licensing opportunity to roughly double that. But if you look at this from a more practical a 20% Share is a $500 $500 million revenue stream. And that's just our first indication. So here's the system. What you see on the left is the console housing the laser in the computer. The real key is on the upper right two probes, one probe delivers the laser energy to the center of the tumor in the saline drip lasers have been used historically, in what I would say is kind of a gross fashion because they cheer they lose efficiency and stop working. That saline drip actually prevents the cheering and improves heat transfer efficiency. But a real key is the parallel probe. It has multiple temperature sensors, it's well understood at what temperature tissue dies. So that gives you true parametric control. So this is how it works. You would localize the tumor with ultrasound, just like with a biopsy. And then you place the laser probe just like a biopsy needle 1000s of surgeons, radiologists do that on a daily basis. You then place the thermal probe at the periphery of your target zone, you heat from the inside out. And when you hit target temperatures in the periphery, the system shuts off and you get real time feedback while you're doing that, and you cannot over treat that tumor is now dead. It'll be resorbed and remodeled by the body like any normal tissue. So not only do we minimize scarring on the outside, which is key, there's no dimpling of the breast which is a common occurrence in lumpectomy and there's none of that opaque scar inside which is left after surgery that interferes with detection recurrence that just doesn't happen with us. The bottom line efficacy is the most important Are there was a recent meta analysis looking at over 7000 lumpectomies positive margin rate of 32%. flip that on its side, that means a success rate is 68%. The American Society of breast surgeons actually recognize this. So a couple of years ago, they set a goal to hit 80%. In other words, they knew they weren't there, they wanted to hit a goal of that. In our last trial, all comers we were well above that. And with the smaller tumors, we were at 98%. So you know, number one anti to the game is you got to be better. And we are by leaps. I mean, if you look at it again, flipping it, we reduce the need for retreatments by over a factor of three. And because of that, we're really blessed. We have a class A list of of hospitals and physicians that are working with us. Our pi for the new study is at Yale. I mean, as I said, we were just at UCSD. and in Europe, we're also using the trial, even though we're approved there many sites in Europe to introduce it to the KOLs. They're specifically in those countries that have existing reimbursement codes, like Germany, Switzerland, in the UK, for example, in Germany, we have the largest Breast Center in our trial to have the next five largest, we have the largest public and the largest private Breast Center in Switzerland, we have Oxford in England, and we have one of the two largest breast centers in Israel. So this is really setting the base for our commercial launch, and for what's going to go forward. We've also been recognized, you know, there's other ablation technologies out there, the more you peel back the onion, the better we look. And it all comes down to data and performance. And I'm lucky that Frost and Sullivan has multiple times done an analysis in this space, every time Nova lays best in space without a doubt. So we can go into that into as much detail as you would like. So I'm here to see if you want to help us with this opportunity to transform how breast cancer is treated. We're ready to go. We're literally launching in Europe as we speak with the first revenue coming in over the next few months. The trial patients recruitment has started that trial will be done next year. And because it's a 510 K by the end of next year, we could be clear and ready to launch thereafter in the US as well. There's existing reimbursement in Europe, where a breakthrough therapy device, so therefore there's a fast path to reimbursement here. All we need is some fuel in the tank. And with that fuel. Over the next couple of years, we'll get through the FDA beyond the market in the US, while having generated revenue in Europe, having proven out our business model going deep rather than broad. And at that point, we'll be in a position to start looking for a liquidity event. So I hope I've interested some of you I'm here for the next couple of days and so is my colleague, John Regan. So if any of you have any questions, I'd be happy to have a discussion. Thanks for your time.