Video Transcription
Natalie Garzorz-Stark 00:02
Hey, good afternoon, everyone. Thanks for coming and for being here. My name is Natalie Garzorz-Stark. I'm co-founder and CEO of Dermagnostix, a dermatologist by training, and I would like to present Dermagnostix to you, a university spin-off founded in 2021. Our mission is to bring innovative molecular diagnostics, precise and objective, into the market of skin diseases. Skin diseases are highly relevant; so, one-third of the population worldwide suffers from skin disease at any given time, and incidents of the most prevalent skin diseases, such as psoriasis, atopic dermatitis, and melanoma, are constantly on the rise. Apart from the fact that skin diseases are very expensive—these are the costs, by the way, in the US alone, 86 billion per year in 2013—before actually the very expensive therapies have been brought to the market, skin diseases impair patients' quality of life more drastically than cancer and diabetes, because you can imagine they're stigmatizing; everyone sees them. The good news is actually that over the past two decades, novel therapeutics have really revolutionized the way we can now treat our patients better than ever before. However, these treatments are very expensive, 20,000 to 200,000 euros or dollars per patient per year. The bad news is that diagnostics has remained barely unchanged over the past decades and century. It's focused actually on visual examination of the skin, both macroscopically and under the microscope, which is done in histology. This causes a really huge gap between highly modern therapeutics on the one hand and barely unchanged diagnostics on the other hand. These novel therapeutics cannot really fulfill and exploit their potential, and this is exactly where Dermagnostix steps in. We want to bridge the accuracy gap in dermatology with Sorex. Our first product that I hold here in my hand already addresses a very relevant diagnostic gap, namely the one of psoriasis and eczema. Ten to fifty percent of patients suffering from psoriasis and eczema are misdiagnosed, and this is particularly important nowadays with these specific therapeutics, because imprecise diagnostics not only make those therapeutics ineffective but even harmful. We developed a two-gene expression-based algorithm classifier that is more precise and objective than current gold standard diagnostics and is the first accurate test on a molecular basis worldwide for inflammatory skin diseases. As you can see on the graph on the right side, the variance between dermatopathologists, which is considered the gold standard, is really broad, while Sorex offers precise and less variance in diagnostics. We didn't want to bring this test just in a central laboratory to the market, but we saw we can only really bring it to the market and make molecular diagnostics a normal reality if we offer it in a fully self-contained system, namely in a cartridge and analyzer system. That's exactly how our products look like: this cartridge, which actually contains all reagents necessary for the workflow, and there's the analyzer that processes this disk, but hopefully many more disks in the future. The workflow is super simple. The dermatopathologist just needs to insert a standard biopsy specimen into the lab disk, close the lab disk, and insert the lab disk into an analyzer like a CD into a CD player, and two hours later, retrieves the result that is displayed on the lab disk analyzer but also transported to a cloud via our connectivity solution. This connectivity solution also allows us as a company to perform software updates and communicate with the customer so that we can really reduce service and support costs, which is very important in a hardware-based business. Dermagnostix was actually really built on the shoulders, I would say, of giants. At Dermagnostix, more than 20 years of biomarker research from the Technical University of Munich and the Helmholtz Center Munich, as well as more than 15 to 20 years of top-notch microfluidics technologies, converge at Dermagnostix, so that we are now able to bring both biomarkers and the technology with our products to the market and improve patients' quality of life. This is also reflected in our board. Our management and advisory board shows more than 100 years of experience in research and science. We have deep relationships with key opinion leaders worldwide, which also offered us a very good commercial entry this year, and we have experience here with entrepreneurs, both in the board and in the shareholder team. Earlier this year, we launched Sorex, our first disk, and Sorex will be followed by further lab disk applications that can be processed with the same device. We plan to grow gradually, both with our product portfolio and across customer segments and regions. For the pathology market that we are currently in, we have the next product in validation with Lymphax that will differentiate benign inflammation from T-cell lymphoma, which is a very severe diagnosis, and at the moment, there are basically no tools available. As I said, we will go across novel customer segments, which are dermatology offices, hospitals, and pharmacies. We not only introduced new biomarkers, but we changed the patient journey and the workflow by offering complex molecular diagnostics at the point of need through non-invasive tape strip-based analysis. This will be for Sorex 2.0, where we differentiate eczema but also fungal infections. The three of them account for more than 50% of all diagnoses on a daily basis at a dermatology office. There will be Pattern X, which is a completely new concept where you assign patients or stratify patients according to the molecular signature, thereby allowing a broad array of diagnoses to be really funneled into the right therapeutic options that are available but not yet tested in clinical trials. We are actually ready for the future to come because at Dermagnostix, we combine all the advantages of a fully automated lab-in-a-box technology, so really minimal time to result. You don't need trained users. It's cost-efficient. You can install it at the point of need, anywhere, at any time, used by anyone. We have our own proprietary biomarker pipeline, so all of our biomarkers and assays are IP protected. What is our track record so far? As I said, we have a strong IP with 28 patents. We have raised so far 12 million in equity and 8 million in competitive third-party funding, non-dilutive. We are, of course, ISO certified, and we have launched our product Sorex, the lab disk analyzer, and the connectivity solution. We have started now to be commercial in Germany, the Czech Republic, and since yesterday, also in Belgium. We are aiming for Switzerland and going now step by step. What is also important to note is that our cartridges can be produced at economies of scale with our shareholder Hart, fully automated, which is also a novelty in the market. There are no manual assembly steps necessary to produce those. What are the next steps? We are about to raise now 15 million in a Series B round. This money will actually be used to finalize the development of the portfolio, as I showed you, but also to strengthen the sales and marketing team going into commercialization, and to roll out our go-to-market strategy for the US for FDA approval. It will be a de novo device, and we want to fulfill and achieve business plan delivery, being cash flow positive from 2027 onwards. I can just confirm, as a dermatologist, that I am really super convinced that molecular diagnostics in dermatology is a sleeping giant, and diagnostics is about to awaken it. So if you want to be part of our journey, don't hesitate to contact us. We have also a booth just around the corner where we can give you a product demo, show you the device, the cartridge, and also what is going to be in the pipeline and what we're going to develop in the future. Thank you very much for your attention.
