Larry Dentice Presents MUSE Microscopy at LSI USA '24

Larry Dentice  0:02  
Our product MUSE Microscopy means microscopy using surface excitation for pathology tissue. And I'm about to share with you that our technology is changing 100 year old process that's still in existence for all pathology, dermatology, whatever it is, whatever piece of tissue they have, I'll show you they go through the process, and they create a glass slide like this, that's two to three microns thick piece of tissue that's done would cost the chemicals. And this is the first thing that happens before you hear about digital pathology. This is now put into an analog to digital device that converts it to a digital image that pathologist can read anywhere in their center or anywhere else in the world. So there's nothing better than an actual example of what this technology does. Women's Health is our is our first target from a clinical perspective. And on the clinical side, if you take a look at women's health, and breast biopsies, where a woman unfortunately may feel a lump ends up going to a hospital or a breast center, where where they'll do a digital mammography. tomogram probably ultrasound as a follow up to see what it is. And unfortunately, in some cases, they say we have to biopsy that tumor to see if it's cancerous or not. And what else is going on? Well, the good news is that eight out of 10 of them are usually benign, only about, you know, two out of 10 patients, actually it is cancerous. The issue is is when they they have to wait four to five days, they take out that biopsy tissue, they have to and I'll show the process, they have to go through an extensive process where they take the piece of tissue, it goes actually to a lab, this stuff is typically mailed to a histology lab, they use caustic chemicals to turn this into a paraffin piece of wax, then they use a microtome, a $200,000 device to cut micron thick slices of tissue. And then they create this class slide. That process takes about three or four days. So anything that happens in pathology, whether it's dermatology, whatever it needs to be done to be looked at, on the histology side takes up typically a week in the US and and could be, you know, two weeks rest of world. So we change that entire process. Because we're a direct to digital device, the within within a surgeon takes a piece of tissue, we put it into our cassette, which would take up to 300 micron piece of tissue, we put it in this in this cassette, this is a disposable device that we will obtain a lot of revenue with, and they put it in our device looks like a cure coffee machine, you can see it there in the middle. And within minutes. We have a pathology image like this here, like on the regular regular slide that can be sent to our pathologist for immediate read. So in the example about the women's health, by the time that woman gets back to the dressing room, the image could be sent to a pathologist and let them know whether or not it's cancerous or not. And it will accelerate the diagnostic treatment cycle. This is true for any piece of tissue right now, we can do about 80% of the tissues on the market. And here's the difference. This this one piece of glass slide, if you miss the margins, or you need to do something else, you need to produce another glass slide before it can be digitized. Because of the fact we're looking at surface excitation, we can go down from 100 microns to 300 microns, you can put a slab of tissue in here, and we can image a depth. So we have XY and Z focal planes that they're able to look at the images. So every time we scan this, we produce about 12 equivalents of the glass slide. And then it's immediately available. Our product has all the formats for for DICOM image transmission. We're compatible with all the Hamamatsu like or all the viewers that are on the market. So we really truly are a direct to digital product that has no predicate device. I'm going for de novo FDA clearance on the product. But we're starting in the this just shows that we have depth in the product and that I'm able to have multiple pieces of tissue in the XYZ plane, I'll get into how that's really a clear advantage because when you look at the images, which, which I'll show you, we do have a great professional team. Here's Dr. Rao at UCLA. We it hasn't changed in 100 years, they were using a microscope. Now they're actually able to take the slides and view them on digital, but everything starts with the glass light approach. From a user perspective, we created a GUI interface where everything is self Touch for the operator will have protocols for liver lung, breast tissue will have individual protocols across the board. With small changes, we can do this in any language for for recognition on the product. So you can see they put the tissue in, it validates it, it automatically we have two cameras, one four, actually determining the region of interest that you can see in the in the middle picture. And then it does an initial scan a native image, that UV image and then we automatically in silica can turn it to an H and E image pathologist are all used to looking at this blue pink haze, because they use an ancient staining protocol. The other piece of this is the stain is destructive, it's very caustic, a history histo Tech has to wear a a badge, and they can only have to rotate every seven hours. When they produce the when I produce the glass slides. For us, we keep the tissue intact. So we're able to do downstream molecular RNA, DNA, all the tissue integrity is held. And in the in the event, they do want to convert it to a glass slide for maybe 20% of the things we can't do the tissues integrity, they don't have to take another biopsy, they can actually use the same piece of tissue. And again, I'm starting with that, obviously, because there's no FDA, I'm working with the three largest companies IDEXX and tech, which is owned by Mars, and and Zoetis. They're all very common names they have about 80% market share. And they're all we're all in the process now of obtaining term sheets for exclusive rights globally, to be able to offer this product on the vet side, we've done demonstrations with their pathologist and then entire teams that have come in to see what we do. So on the human side, I mentioned we're going for FDA next month. And we're going to start with women's health. So just to show you this is a native image showing tissue of a dog, we think this is could also be used for pathology art, somewhere down as a as a side business. But when when pathologist take a look at our native images, they get very used to them. They're used to looking at the native the H and E type of image, but we're able to have them make diagnosis off of the off of the native images. Now because they see the depth, they're able to see multiple focal lengths. This is breast tissue, you can see that we converted immediately to an ancient E for a pathologist. And then we can we can zoom in where they can see the cells on the nuclei and everything else. So we produce these type of images in minutes instead of days. The next step, of course, is AI, we are talking to the AI AI companies, we want to continue those types of discussions. Because we have a Z stack of data, we're able to be the we believe that pervert preferred provider, because you're not just looking at a digitized 2d image. We have a full dataset that they'll be able to look inside cytoplasm versus data, everything will be individual. So a lot of headroom on the AI side. We also have full storage capability. Everybody asks, What are you going to do with the cassette in the images, we have that side of the business all lined up with partners that we have from a radiology perspective. vernix is here at the meeting, they help us get this to our production product. So my hat's off to Vera annex for and their engineering team, going from a research project to an actual clinical product. And now I'm using PI product innovation, they're planning innovation, they can produce quantities for 1000 up to 5000. For us globally for for mass production. I've got an incredible team like everybody talks about it's all about your key opinion leaders in your medical staff. So I have both on the Veterinary and the clinical side for for human health. I've got an incredible team for the FDA that are already in line for it. And I wanted to thank you open it up for any questions.