My name is Sanna. I'm the CEO of Lumito, started in August 2024. I received a question a couple of times: Why did I decide to join Lumito? Of course, there were many reasons, but one of the most important being that this is a company with a product, with a purpose. We want to contribute to advancing healthcare through advanced tissue diagnostics. I'd actually like to start by sharing a story. How many of you know this abbreviation? This was the post-it note that the nurse put in front of the physician that was examining me, apparently just received the results from the tissues that were taken a couple of weeks earlier. They didn't know I work in tissue analysis, and they didn't know that I had read a lot on this EIN just a few months earlier. EIN is Endometrial Intraepithelial Neoplasia.
What is that? That is the preliminary stage of uterine cancer. Why had I read about this a few months earlier? This was my first slide last year at BioStock Life Science Summit, exactly one year back. I wanted to talk to our products and what we are actually doing and the purpose of the company and the problems we are solving. In the news at that time, there were more than 30 women that had been misdiagnosed with EIN or the preliminary stage of uterine cancer. The cause for this, mentioned in the media, was subjectivity in tissue analysis, that subjective assessments of tissue. The other one being that the routine of two pathologists double-reading the tests was not done. At Lumito, we are addressing both of these shortcomings. We are increasing the objectivity in tissue analysis by providing quantifiable results.
We are also working in the space of digital pathology, which enables pathologists all over the world basically to co-read digital images. This is a well-known mitigation for the global shortage of trained pathologists. Fast forwarding and back to my post-it note, standard of care process, nurses, doctors, everyone that was involved in my process less than half a year ago was absolutely fantastic. In the back of my head, I had this notion: My samples are going to be assessed with subjectivity. That even more put sort of more to my heart on the company and the purpose. There is a need to reduce the subjectivity and also reduce the risk of human errors within tissue analysis, both in the research field and in the clinical field. At Lumito, we are using nanoparticle technology for increasing objectivity.
We are providing biomarker detection systems that, with improved sensitivity, accurate and precise quantification over a wide range of biomarkers in the tissue, and also a perfect match of where the biomarker is expressed in the tissue. All of these parameters are important to increase the objectivity. To give you a view, the picture to the right, you can see that being not being an expert, you can probably count the cars and see the colors of the cars. If you're well-trained and maybe have this as your day-to-day job, maybe not a trained pathologist, but if you're trained at looking at cars from a distance through a blurry picture, you could count them, you could probably see the colors, but you need to be an expert. If I put this in context of tissue analysis, biomarkers are stained, labeled, colored in different ways.
One of the most commonly used ways is to stain or color them with blue or with brown color. This is not very easy to quantify. In many cases, this is assessed as this light, dark, very light, very dark brown. What we're doing with our solution, this is the same tissue sample. We use the nanoparticles, attach them to the biomarkers, and the green light can actually be measured and give a quantifiable number. This is also recognized by a U.K.-based CRO who has been evaluating our system. As you can see, they're comparing the brown-ish view to our solution. Of course, I need to show some cool tissue slides. This is one. I'm not going to go into the details. This is breast cancer tissue. It's stained to be able to see the different cells in blue and the membrane in brown.
When we add our biomarker detection system, you can see green lighting up. You can see the precise location. They're present in the nuclei, and we measure the light in these images and get quantifiable data out of that. The workflow in tissue analysis and tissue diagnostics often starts with, of course, a biopsy from a human or an animal model, but then thin, thin slices are put on glass slides. You put some kind of coloring to that to be able to see the cells, what is the nuclei, what is the membrane, and so forth. There is typically a way of labeling or coloring the biomarkers. Our solution, a reagent kit and a scanner, an instrument, fits perfect plug and play into this ecosystem.
That's absolutely necessary for a new player in the market to be plug and play, not adding any complexity, and we do that. With our kit, we get this coloring of the biomarkers in the tissue. It's read in the scanner, and we get digital images as an output. The images can be further analyzed or worked with in commercially available software or the software that we have developed together with our German partner, Katana Labs. Looking into the nanoparticles, of course, there has been tried out before to use different ways to improve tissue analysis. Small particles have been used. Ours are superior in terms of stability, biocompatibility, and manufacturability. In addition, we have strong IP for using our nanoparticles, so-called up-converted nanoparticles in tissue, and they can be used to detect any biomarker in any tissue. How is that possible?
Looking at here, this is a picture image. This is the thin tissue slide or slice on the glass slide. The user, the customer, would then add antibodies. That's exactly what's being done in the current workflow, so no specialties. Our nanoparticles are attached to any of these antibodies and then visualized through our system. I'd like to sort of move forward to the market potential. The area of tissue diagnostics is growing with an 8% CAGR. If we look into digital pathology, it's 10% CAGR, even more. The driving forces to this are aging population, more prevalence of cancer and chronic diseases, but also the development of more potent drugs and precision medicine. We are in the research space. We have a CE mark product for research use only, so we can address half of the market today: research laboratories, pharma companies, contract research organizations.
We're aiming for clinical, but that's going to be later. Our total addressable market globally is $1.8 billion. Zooming into Europe, where we're operating at the moment, $470 million, and we think we can grab about 3-5% of this. Our business model includes recurring and non-recurring revenue, non-recurring through scanners, hardware. It's either a purchase or a lease agreement, and then services and kits as the non-recurring revenue. We can have users having the scanner on site, or they can send the tissue slides to us for scanning, and this is enabled by the exceptional stability of our particles. We are leveraging contract research organizations to get an efficient and scalable model to reach many users. We need to get awareness for what we can do and for our product.
We also want to partner up with pharma and diagnostic companies, and we want to work with academics to expand the application areas for our platform, leveraging key opinion leaders and reference customers. This is a case study for this British or U.K.-based CRO. They first got to know about us about a year back, and through different steps, they have now included our solution into their offerings to their customers. This is the first one who has done that. We are early on in our commercialization journey, but we see that this process can be speeded up when we have those reference customers. Revenue generation will obviously start when they have customer projects that are using our solution. Again, scalability and reach.
There are more than 300 global—I mean, this is a difficult number to estimate, but there are a big number of CROs globally and in Europe that are relevant for us, that are working preclinical and that are doing tissue analysis. Behind a company, there needs to be a good team, and we do have a really experienced and professional team. I want to point to our scientific advisors. These are not only our advisors; they are really also providing a global network and opening doors into this ecosystem for us as a new player. Paul Waring, who is the Chair of the Board, he is an active pathologist still, but he's also had a number of years at AstraZeneca and at Roche. This is a super important team for us. What's up next? We are well prepared for the next step in our commercialization journey.
We have now two leading CROs offering our solution into their platform or into their product offering, and we want to get more, obviously. If you're a CRO in the audience, please come and talk to me afterwards. We have manufacturing agreements both for the scanner and for the kit. We are ISO- certified. We have an advisory board in place that we received earlier this year, and we have just completed the rights issue, which gives us financial runway. With this funding, we are stepping up based on the solid foundation we now have. We're stepping up on our commercialization efforts, adding business development, adding sales capacity, adding market presence capacity, and so forth.
We're also restarting a strategically important project for us that we have had ongoing, needed to pause to focus on what we have at market, but now we're going to start this project, making sure that we can offer multiple biomarker detection in tissue. This is really important for us and to add on to our value. Key milestones for the future, obviously, to start generating revenue from the CRO partners we have, but also working with more. Leveraging, engage with pharma and diagnostic companies and others in this field, and also the academic research, because I am sure there are application areas out there that we don't even know about yet due to this open platform. We know there are challenges, and we know we can help solving them. By that, thank you very much for listening.
You talk about scaling application here.
Is there a quantifiable target in terms of, for example, sales that you can talk to?
I'm not going to talk to the quantifiable target on sales. Maybe this is a bit shying back, but for us now, it's really, really important to get going with sales and revenue generation. The way to get there is to partner up with more partners that will offer our solution, but also going direct. I would love to come back in half a year where we have gone a bit further in our journey and talk to actual numbers.
You're obviously always welcome back. As a final question, how will you prioritize the rollout in Europe versus entering North America?
My advice is, knowing that there is a huge market in North America, we need to get Europe right before starting to expand. We are obviously open for opportunities.
We are able to have our kits being used in North America, and we are able to partner up and get those collaborations going. We have advisors based in the U.S. who are helping us with those door openers.
Thank you so much, Sanna.
Thank you so much.