Scott White, Delphinus Medical Technologies - TriAD Technology for Breast Cancer | LSI USA ‘24

Scott White  0:00  
Scott. So I'd like to talk to you a little bit today about our effort to transform early detection and breast cancer. And my name is Scott White. I'm the president and CEO of Delphinus Medical. So real quickly the agenda, I want to walk you through the problem, because we got to believe in the same thing here. We got to figure out, how are we going to save women earlier detection, the solution, we believe we have part of that, the clinical evidence that supports that solution, the market opportunity, and ultimately, our team, which we believe passionately, is going to bring this to market. So what's our mission to tenaciously create and deliver medical innovations that transform early breast cancer detection, very important for women all across the world, and we're very focused here in the United States. By the way, delphiness has been in business for 10 years. We got our FDA indication as a PMA approved device in October of 2021 we've been pre commercial up to that point in time, and in 2024 we're moving forward commercially. Don't want to start with a very provocative statement, by the way, sofu is read in combination with mammography, but for dense breast women, mammography is not enough. I'm going to say that one more time, mammography is not enough. But every woman aged 40 to 74 is focused on mammography every year, and it's important that they stay that way. But more is needed for women with dense breasts. So what are we talking about? Breast cancer is significant disease burden, most commonly diagnosed cancer in women, second leading cause of death for women. So we all have family members that have had cancer. You may unfortunately have had someone you know that's had breast cancer. 40,000 women a year die from breast cancer. This is an important stat, because this number has not changed for years. So what's that mean? It means that we're not doing enough. The medical industry is not doing enough. The physicians, all of us, are not doing enough to save these women's lives. So let's talk a little bit more about the prevalence. So when you're age 40 to 74, 100% of women annually should have Mammo, and that's not a great exam. And talk to any woman in your life, and they'll tell you that my wife is one who reminds me every year when she has to go back for her Mammo, it's not enjoyable. 10% of the market has high risk. That's two or more risk factors, dense breasts being one of those risk factors. What does that mean? It means they skip over supplemental screening, and they go right to Mr they go to some advanced tests, like contrast, enhanced Mammo. The majority of the market, though, is a single risk factor that's low to intermediate risk. That is where sofu plays our technology called sofu, and 38 million women across the country ultimately need to have this test. So again, we're talking about Mammo not being enough in dense breast Well, why is that? Well, you have a four to six times greater likelihood to develop breast cancer if you have heterogeneously dense or extremely dense. That's a birad C or D category, 70% of women that ultimately you find cancer in ultimately have dense breasts. So there's a combination and an integration here. So what's being done about it? So I think if you're a woman, or you know someone, and you have a woman in your life, your mom, your grandmother, your aunt, your sister, your wife, et cetera, they've been informed about their dense breasts, so they may have been given a letter like this woman on screen, but it doesn't mean that you are given guidance. So you may go back to your gynecologist or your internal medicine physician, but what do you do? Where's the test? What test do you need? So they live in limbo, and most women will sit at home for 12 more months not worry about it, and then go back and get their annual Mammo. Again, that's not effective. So this year, the FDA, the government, through mqsa guidelines, are now saying, as of September 2024 more must be done, and women must be counseled. We believe this puts the onus on the on the breast Imager or the imaging center to give guidance to the patient, versus just sending them out the door back to gynecology or internal medicine. So we want to help these folks get better at counseling. So what's the solution? So we believe sofu, our technology, which, again, we went to PMA approval in and 21 offers a very unique and distinct solution. This is a this is a prone water bed, warm water bed bath that ultimately has a very unique and novel way of taking images. We offer a unique circular, triple acoustic transducer that goes from the breast nipple to the chest wall. We will take images of anywhere from 40 to 65 slices, both left and right breast, and ultimately put those in a very unique image for radiologists to review. We are a transducer image. We ultimately provide reflection imaging, that's ultimately ultrasound, but in combination with TomoTherapy. So what's this technology do for us in the market? Find more cancers, prioritize the prioritize the patient's experience, which is critical, and I'll come back to that, improve workflow and ultimately offer financial benefits. This is a CPT code that exists in the market. We're not looking for reimbursement. It's out there now, and it's a tremendous two year payback for most facilities. So three pillars of our performance, reflection, sound speed and attenuation, specifically to our transducer ring, our razor razor blade model. That razor blade being our secure device, which is. Soft gel pad that ultimately gently suctions the breast. The real difference in how we take images is we elongate the breast as the patient lays prone, ultimately separating those tissue planes we believe that allows us to see lesions more effectively, and then ultimately we're gathering enormous amounts of quantitative data so that ultimately we can enhance the clinical interpretation. So there's an opportunity here to include AI in our solution as we move forward. So three easy workflow steps, because our competition in the market today, we don't think that there really is any. We think that it's status quo. So status quo for our breast radiologist is the thing that we're trying to overcome. But when a patient walks through the door, we play secure into the sofu system. The patient is positioned and lays prone. It's a three minute scan on the left breast, three on the right. Total of 10 minutes for the patient exam. And then ultimately, we're examining the patient through the triple acoustic transducer. This is the result of that image. You'll get four distinct images, wafer, reflection, sound speed and stiffness, fusion. This allows for the radiologist to read both sofu images and mammogram images combination, and ultimately read out and post their document. So in our in our PMA approval, what have we done? Why is this novel and also realistic solution in the market? Because we increase sensitivity by 20% in combination of being read with mammography and we do what other technologies don't we reduce we reduce that callback rate. And this is why most breast radiologists don't want to use handheld ultrasound in their solution, because they're following a lot of benign pathology. So we've got to improve sensitivity and specificity. So that's what we do here with sofu, a number of 510, KS, obviously, we've done our homework. We've been working on this now for a number of years, a number of peer reviewed articles, chapters, et cetera. So we're very excited here, but this is the data I mentioned I wanted to come back to so with over 6000 patients out of an 8500 study for PMA, these 6000 women took a post op surveillance and they said that they would have this test done again, or they would refer a friend. Just think about that experience. We don't have this data yet, but I wonder what that real, what that real reoccurrence rate is with women coming back year over year, we can increase that. So finally, in terms of growth, we're at $3.3 billion capital market opportunity. We believe that there's both capital and obviously the reoccurring revenue that we drive 38 million women just in the United States alone. Again, we talked about this capital solution, capital and disposable razor, razor blade. We also have both a capital solution and we also have what we call our now program, where we retain the cost of the capital and it's just a per click model for our sites. We believe huge CAGR over the next three years, almost 350% so this, this is ultimately all three revenue streams, including service. And then these are just some of the customers that we currently have contracts with and or that we working deep in our funnel. And you'll see both academic sites, tertiary care, and we've really made a pivot recently commercially to focus on imaging center management firms across the United States, folks like radnet, red partners, Simon Med, Reyes, et cetera. These are the more entrepreneurial sites that ultimately move faster through acquisition. Two more things to share with you. We've got some road shows where we're educating women and we're giving women their voice back, and we want them to tell their providers that they demand this type of technology. So we are taking our message directly to women. We just did this in Grand Rapids, Michigan, by the way, our home is Novi, Michigan, right outside of Detroit. Everybody, everybody versus Detroit, so to speak. So we kind of have adopted that turns up changing the market. So we'll be in New Orleans working with one of our customers there in May. We'll also be in Austin very soon also. And as far as our investors and board, the best board I've ever worked with, and I don't think I have any board members in the audience, so I can say that, but you can see, we've raised over $130 million we just completed our Series E, and so we're really set to move forward. So what, what is the ask here? Is that my is that my choker? I got I got eight, I got eight seconds left. So what are we asking for partnerships and development, and we're looking for further investors. We will raise more money, and that will go towards moving into other markets around the world. Thank you very much for your time. Thank.