Vicki Farrar, Light Line Medical - Disinfectant Using Visible Light | LSI USA '24

Vicki Farrar  0:01  
A question for everybody here, are you afraid to go to the hospital? You should be hospital acquired infections are a huge international problem, and more more than 40% of them are catheter related. They're costly, they're deadly, and in the United States, penalties are of the hundreds of millions of dollars annually. Do we care about catheters? The answer is yes, they're one of the best medical miracles of the century. But infections limit their use, limiting care. Why? Why can't the whole world fix this problem? It's because so many of the drugs used to treat these infections are antibiotic resistant. Fact, antibiotic resistance is the third leading cause of death worldwide. We have the solution. It's called the light line photo disinfection system. We're using visible light. That's light that the human eye can see, not harmful, UV light. The technology consists of two components, a reusable light engine attached to an off the shelf catheter. Inside the catheter is a fiber optic that emits light inside and outside, disinfecting it and thereby preventing infection. There is no antibiotic resistant issue. First, the technology is going in a peritoneal dialysis catheter, followed by urinary, respiratory and vascular the device works. We've successfully killed the microorganisms that cause these infections, and exceeded FDA is 99.99% kill rate, and this month, an FDA certified lab verified our results that will be submitted to FDA in a couple of weeks. But why? Why are we working with peritoneal dialysis? First, several reasons. It's generally understood that peritoneal dialysis done in the home is better for the patient clinically and their quality of life than hemodialysis done in a clinic several hours at a time. Then how come in the United States, 89% of the populations on hemodialysis, it's because they're scared to death of getting an infection, and we can fix that. But the second reason this is our first product is because we're putting the product in the extension set which is outside the body. As a result of it being outside the body and not touching human tissue. We don't need to do animal clinical trials, so we have a straightforward 510 k pathway. But next, next is the holy grail. We put the technology in a foliar urinary catheter to prevent catheter associated urinary tract infections. These are the most common infection in the whole world, not just the United States, it too is a 510 k, but it's a de novo 510 k. We need animal and clinical trials. That's why it's product number two. We estimate that five years post launch for our first two products, revenue will exceed $300,000,000.10 years post launch for all four products, they will exceed $1.7 billion we have a distribution partnership model. We rely on a partner's market penetration. And for the urology product, we have that partner. It's Medline industries, the largest private distributor in North America with 50 infectious disease sales reps. Here's how we make money for peritoneal dialysis. We have a razor, razor blade model. We give away the light engine for free. We charge $70 once a week for the fiber optic. That's an 80% gross profit margin. But for all other indications, we charge for both the capital equipment and the fiber optic, but you only need one fiber optic for the length of time that patient is in the hospital. Competition. Standard of care is sterile technique, gloves and alcohol swabs. It's clearly not enough. There are also antimicrobial coatings, like Bard silver coated coating, but silver degrades over time, and those antimicrobials only cover the exterior surface of the catheter, not the interior. Two companies with products and development, one is using bleach, one is using UVC. Both are toxic, so they cannot, under any circumstances, be put inside a catheter, inside a body cavity only light lines visible light. Does it all works with existing catheters, does not degrade material and significantly disinfects the inside and outside of the catheter. But why would anybody buy our products? It's because we have a strong value proposition for everyone. Patient doesn't get an infection, caregiver isn't treating it, hospital isn't penalized for it, and the insurance company isn't paying for it. How do we know we can get the products on the market? We've all done it before. I have deep intellectual property experience, and sold my last infection control company, catheter connections to Merritt medical merit, put a million dollars in Lightline. My co founder at catheter connections is Bob Hitchcock. He's our Chief Technology Officer. He's been putting products on the market for decades. Kerry habis, over a decade of experience. And Kelly powers recently retired from CR Bard in. Access. He's put over 100 medical devices on the market with revenues exceeding $15 billion we're finishing up our Series A. We have 240,000 left. We will oversubscribe 18 million pre money valuations, 69 cents per share and 8% warrant coverage. We're also seeking a leave of $20 million for Series B. We have several strategics that are circling us right now for that, here's how we're going to use our funds. All of series A is going to everything we need to do to file that 510, K and answer FDA questions. There will then be an increase in valuation and we raise a series B. Series B will be used to commercialize the peritoneal dialysis product and develop the Foley more than 50% of it will be used for animal and clinical trials for that, then we'll be revenue funded, followed by endotracheal and vascular development. And I want to point out that we are talking right now to three public companies about our vascular technology. This is a snapshot of where we are. We've reached agreement with FDA on our regulatory pathway. As I mentioned, we're filing that 510, k in the next few weeks. We've done over 50 in vitro studies. This works. IP is our secret sauce. Over 30 issued patents, 18 pending written freedom to operate, opinions and own everything free and clear. Now understand, it's not the number of patents that matter. What matters is that examiners all over the world have found their technology novel. We have three World Class collaborations, one with mayo. Mayo is an investor, and I'll get to that in a minute. I've talked about Medline right now with DaVita. We are in davitas clinics throughout the country, doing our simulated use studies required for FDA, we've won lots of grants and awards, and we've raised over $11 million to date. Our agreement with mayo is significant. We've licensed from them their know how, in all four fields of use, we've had the distinct pleasure of working with a nephrologist there once a week to get our product right for males, patients as well as others, we secured funding from them, and they negotiated best price. And here's what that means, there'll be early adopters and a catalyst for others to adopt our products. Exit. We have eight potential exits, four fields of use. Can do a deal internationally or domestically. In each example, verzenius is a dialysis company. They're only interested in dialysis merit and Bard may want selected indications in selected geographic areas. Teleflex and Medline want, want everything everywhere. And I want to point out that of these potential acquirers, we already have relationships with three of them. So here's what we want you to do. We want you to invest, and then we will provide better patient outcomes for millions, save hospital billions, launch our product timely, have potential revenues in excess of a billion dollars, and deliver extraordinary returns to investors. Catheter, infection, mission accomplished. Light line medical is changing the way the world prevents infection. Thank you. Thank.