Frans Cromme Presents ViCentra at LSI Europe '23

ViCentra's Kaleido device is a new insulin delivery system designed to give patients with diabetes freedom and peace of mind, with a focus on device customization.
Frans Cromme
Frans Cromme
CEO, ViCentra



Frans Cromme  0:05  
Good afternoon, everyone. So in the next time ministers like to tell you about another important field, which of course is the burden of diabetes, what we seek out to do with ViCentra is to improve the quality of life, people struggling with insulin dependent diabetes. And as you probably know, there's a massive burden for diabetes over 500 million now, people being diagnosed, of which at least 30 million are insulin dependent. And funnily enough, only slightly more than 2 million of those use insulin pumps, although they've been proven to be clinically better outcomes, the majority of people are still on using pens. And I'll tell you why in a minute. Within the 2 million pump users by three or four key manufacturers, by far the fastest growing segment is what we call wearable pumps. So pumps you can actually wear on your skin. And that improves the quality of life. The value between Europe and the US, which is the vast majority of the market is currently around 4 billion. That's purely the pumps. It's not the insolence of the CGM, the glucose monitors, it's just the pumps growing high single digits. And other pumps have been around for 20 plus years, the majority of people are still on multiple daily injections using small pens. And the reason for that is that today's problems are mostly very bulky and complex to operate, and take into account that most people are diagnosed with type one diabetes, specifically in their teens. So if you have a teenage daughter or son, and they need to start wearing a pump, like the Medtronic pump in the middle, it really Shouts out to the world that you have a complex medical condition, and wearable pumps that are either hidden or easier to use, because they're good to look at and simple to operate, we think changes that that's what we're at. So we've developed Kaleido, which is a system that is so small, you can wear it on your skin, you can also choose to wear it in your pocket. It comes in 10 Beautiful colors, because we try to de stigmatize the condition and at the same time have a system that is really simple and reliable to operate. Comes in two pumps, instead of two pumps, you get to choose your crawlers that allows you to personalize your system and a little handset. And every month you get 10 cartridges and infusion sets. The user fills that with insulin themselves that's custom in this market and then attached to their body for the next three days for insulin delivery. And the reason we're different from others is on three key components. So this is the investor pitch. First of all is very small wearable compared to most of the other pumps, but at the same time very precise, and others have made significant concessions in that combination. And third is because it's a durable pump that can be recharged for four years to full reimbursement cycle, and you only dispose of off some pieces of plastic is also low cost of goods. So let me show you each of these a little bit in detail. So this is where we compare both volume and weight of the pumps that are out there on the market. Medtronic being by far the market leader plus 40% market share the latest generation is 130 grams in over 100 square centimeters. If you compare it to us, it's 19 grams. So that means that after a couple of minutes, you don't notice you're wearing it, the amount of insulin they carry is all more or less the same. The most successful system at the moment is the penultimate one, the Omni pod pump, currently growing very fast close to 400,000 users because it is a wearable pump. So let's size precision that is because we're the only one that is not a science based pumping principle. It has its own pumping principle. That's also where our IP sits, which allows it to be very small, but at the same time very accurate. You can see that in the graph on the right, which is demo one of the leading institutions in Germany. They measure all the pumps that come to market. And you'll see that every pump ideally tries to be on an accuracy of plus or minus 5%. At the lowest possible dose Kaleido RCM is factually the only one that hits that consistently because of the pumping mechanism. And third is cost because you reuse the pumps, which is the expensive components and you only dispose of the cartridge which are made of simple pieces of plastic we put together in our factory through welding technologies. The costs are low at scale. If you again compare that to Omnipod, which is a fully disposable system, very successful and easy to use very successful in the US particularly, it's a fully disposable pump. So you throw away a full pump every three days. tremendous difference in eco footprint and in cost. So that's the investor pitch, the patient page if you like we actually call them people and not patients because it's bad enough if you have type one diabetes. For people, what we really try to do is offer something that is around personalization and flexibility because every person has different needs. So why should you have a standard pump? That's why we go through the effort of having 10 Different colors which is really a pain in manufacturing. But it is really important for users use if you get to choose your color and combination it becomes your system and your kit. You can use it in a manual mode with our system But we're also linked with Diabloop, which is one of the most disruptive companies today in developing algorithms to take the readings from a blood glucose measurement system and then automatically dose the pump. That means going forward, you only have to announce your meals, and the rest is done fully automatically massive improvement in quality of life. The top part is where we are today being on the market in three countries. The bottom part is what we will launch over the next two years where you essentially move to control it from your own smartphone. Again, simplicity and ease of use will drive adoption. We've tested this in our previous pilot phase and quickly grew to around 700 users in the Netherlands coming from both conventional pumps, but mostly from pens. So mostly people that struggled to move to pump therapy until they found something that was simple and easy to use. And they were very happy with it. Our largest challenge was manufacturing is that to make something so small, reliably turned out to be really, really difficult. And several other manufacturers have failed to move to wearable technologies in the past. So he spent a lot of time and effort and capital to really get the product over the finish line and build our own in house production lines. We recertified our CE mark, we're in the final stage of our MDR and hope to get into your approval by the end of the year. And now with over 500,000 user days of testing, do production lines in house, we're ready to go to go big time. So we're live today in the Netherlands, France and launching in the next couple of weeks in Germany, try to get to 1000 1500 users, which is still small, and then five to 7000 users by the end of next year. And if you're talking revenues, that's low single digits this year 3-5 million, 15 to 20 million next year now well over 100 million over the years to come compared to everybody else out there are out there that is still relatively modest if you look at the size of the market, but it's more enough for us to finance and drive good revenues. Team, very important Temoxe, who's up there is the founder and the inventor of the technology, one of the brightest people in the industry. We believe he's still with us working on the next generation and on the app design. But also we brought in and that's the role on the bottom really people with far more experience in either manufacturing scaling, in FDA approvals, and in scaling our r&d operations. And also at our board level. We have two veterans, Jana, Ram both have 20 plus years. Well 30 plus years of experience in medtech. Last slide. So where are we on the financing, as we finally are commercially live is we hope by the end of the year to have a proof of performance in the market 1000 to 1500 users in three markets driving the revenue MDR approval and proven manufacturing capability. That sets us up for our next series, which is a series D, which is a 30 plus million rounds. We've got a confirmed interest from a couple of other venture capitalists and a strategic. So we're trying to close that round by early next year to do three things essentially is further scale our manufacturing capability, because the capacity we have today allows us to grow to 7-8,000 users. So we need to invest in more production lines, get our FDA approval in the backend 25 And last but not least develop our next generation system. And I think with 50 seconds on the clock. That is me. Thank you. If you got any questions please come to me after the talk.

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