Good morning and welcome to the Q1 report from Lifecare for 2025. This Q report will also include a strategic update on Lifecare's view on our path to commercialization. First, I will go through the operational highlights, then the strategic update, an operational review, and then the CFO, Renata Kaarvik, will do the financial review before we sum it up with a summary, an outlook, and a Q&A session. This time, it's not possible to bring your questions forward orally, so you have to write them in the Q question section in the Teams viewer. I urge you to start to write those as early as possible so that we don't close down without covering all the questions that might occur. Otherwise, it will always, as usual, be possible to contact me or anybody in the team afterwards with the questions you might have.
Once again, please ensure that you start to write your questions so that we notice them before we close the session within a short hour or so. The Q1 operational highlights, first of all, it's important to emphasize the fact that we just received new numbers from the International Diabetes Federation with an updated prediction of the current estimate of numbers of people living with diabetes in the world and also estimates going forward. As of now, as of 2024, actually, the International Diabetes Federation calculated that there is more than 600 million people living with diabetes. That is, of course, just highlighting the need for our technology. On the other side, it's also, of course, an interesting commercial development seen from our perspective. In the first quarter, Lifecare has continued to advance towards our market launch.
In the meaning that we are working hard on our design optimization, this is on track to reach our design freeze and manufacturability. This must not be misunderstood to the extent that we have done significant changes in our design. This is more a question of the actual miniaturization of the technology in addition to our core technology, meaning things as the electronics, the receivers, the antennas, etc. Those additional aspects of an implant, we have been working hard on those over the last months, and are now close to do a complete design freeze for our implant in addition to our sensor. The implant design freeze is very much related also to the manufacturability. We have, at an early stage, told that we have automated some of the manufacturing processes.
However, the totality of the production has to be aligned with, of course, the design so that we're able to go into an efficient, scalable manufacturing as soon as we take over our—not necessarily as soon as it will take some time, but when we take over our production facility in Mainz later this year. Throughout the first quarter, we've also improved our sensor chemistry. This will enhance our outlook for accuracy in terms of data and also following that, the performance of our device, reasonably to expect, providing sensitive, good data also for the end users. We have, throughout Q1, updated our strategy, our priorities, and also are ready to make some comments on our commercialization progress. I'm going to go into the strategic update first and our path to commercialization.
First of all, I want to just remind all of us that we are a Medtech opportunity. I emphasize that because we are in a risk perception different from what you would see in any biotechnology companies. We are within the same main segment as a health or lifestyle company. However, the Medtech opportunity that we provide is based on a high-growth outlook. Our specific opportunity is then, as we all know, within the next generation of diabetes Medtech, which in total we calculate to an addressable market of more than or around $5 billion. We have laid out a capital-efficient path towards our commercialization, and we see now that we have near-term value inflection points that will bring us, of course, rapidly into the commercialization phase.
We also want to highlight in this opening statement that we have a second-mover advantage, meaning that we are not the first implantable; we are the second implantable. We envision that as a huge advantage as the first mover within the implantable market for continuous glucose monitor has already been through the regulatory path, meaning that we are not a new product. We have our own technology; we are a new product, but in a regulatory sense, we are not the first who are doing these implantables. We see that as an advantage in terms of efficiency towards market approval. We also have made some assumptions. I will come back to that, but already now to state that we see that we have a peak revenue potential based on our calculations of around $1 billion, and we expect to see that in the 2030s.
As already touched in on, diabetes is an unsolved growing global health crisis. It is a trillion-dollar healthcare challenge, and there is a huge amount of people living with diabetes, of which 110 million need glucose monitoring. To underline kind of the seriousness of this is that the fact that diabetes caused more than 3.4 million deaths in 2024, meaning that you have a death every sixth second. It is easy to understand the rationale behind diabetes technology as an emerging market, as a strongly emerging market, because this really affects so many people's lives. Our vision is then, of course, to help people with diabetes to live a better life and improve their life, basically. Continuous glucose monitors have become the de facto standard of diabetes management.
Originally, at least from the 1970s, to prick blood glucose from the finger and to put the blood into a meter has been the usual way of tracking your glucose. This is an on-demand measurement method that will not give you any trend indications, but it will give you a picture of how your blood glucose is exactly at the moment when you measure the blood or take the blood from your finger. Starting around the year 2000, the first continuous glucose monitors came on the market, and from 1999 and up till a few years ago, that has been dominated and is still dominated by the body-worn CGMs, the one that is on the body.
As a variable, there are some limitations in this technology, especially in terms of the longevity of the sensor, so that in addition to having it body-worn, you also have to change it every 14 days or maybe 15 days if you're lucky. That is, of course, an additional effort for the patients with diabetes. Our expectation, though, is to go into the future with our inject-and-forget solution, where we inject our sensor or our implant under the skin and leave it there for a very long time. Continuous glucose monitors is the fastest growing diabetes technology segment. We have seen that for quite a while, and we see that that will continue in that direction.
There is an estimated more than 12% annual growth from 2022 to 2030, which brings us into a market opportunity in Europe and North America by 2035 of more than $30 billion. Our segment, however, is the subsegment of continuous glucose monitors that we define as the implantables. We see that this is definitely the fastest growing segment within CGM technology moving forward. As of today, as of 2025, there is one player on the market. It's Eversense, and they have a customer base of approximately 5,000-8,000 users worldwide, especially then, of course, in the U.S., as that is their focus.
Based on our predictions and on the sources given here, we estimate that the growth in this segment will be extreme going forward, and we look towards a $5 billion market opportunity for the subsegment of implantables in Europe and North America by 2035. The future of CGM is unquestionable, but the question is, of course, what sets Lifecare apart. The first important thing from our side is the fact that we are implantable, that we have a very long duration, and of course, that we also use the osmotic pressure as the sensing principle. We are the only ones who do that. We have ensured to be widely patented to the extent we can patent our device, our chemistry, etc.
We also see that on the basis of doing osmotic pressure, we also expect to have a sensitivity that will be very interesting going forward. As of today, we have calculated that we have a mean absolute relative difference of less than 10%, as all of these technologies have. This is important because the mean absolute relative difference, the MARD, needs to be below 10% to be clinically accepted, meaning to provide information that makes the patient take decisions on how much insulin to take, which is important. Given our sensitivity, basic sensitivity, and also the sensitivity improvement we have done, we have reason to expect that we will have a sensitivity that is really good.
I'm not going to quantify that, and I'm not going to say when we can quantify that, but I think it's reasonable to expect that we will be able to get a bit more into that throughout 2025, and I look forward to update you all on that going forward. As of today, we have developed our product into a small capsule, as has Eversense. We have a slightly lower duration period than Eversense. That is not because we believe it will stop to work after 180 days. It is because we don't have data that supports that we will go beyond 180 days. We expect, based on our technology, that we will be able to far outplay the 365 days that is the state of the art today.
In our future product, which will be a grain of rice, we expect to go at least into one and a half years. I think it is reasonable also to expect that our current product will have a duration longer than what we are stating here, but that remains to be proven, and we will come back to you when we can prove it, of course. We are working, of course, to translate the exceptional market growth into a value for our shareholders.
To put some numbers on this, we have assumed that if we have a 15% technology penetration, meaning if the implantable technology grasps 15% of the continuous glucose monitoring market, and Lifecare is definitely positioned to grab a 25% share of that market, we expect to have a base case peak revenue of slightly less than $1 billion with a potential for more. I just want to also highlight that we expect this to be a sustainable revenue, not like you would see in the biotechnology world, where you would see a peak revenue and then a decrease after that. That is based on the fact that the number of diabetes patients is continuously growing, meaning that going forward, we do not expect that the peak revenue will decline in the foreseeable future.
In addition, of course, to our important effort to go into the human diabetes market, you probably know that we're also doing a pet market approach, a veterinary market approach. This is an interesting opportunity for us. There is a lot of potential revenue to pick up in this market. I want to also be very clear that the reason why we do this is first and foremost to have a positive impact on our human market readiness. We utilize our existing technology and our existing and on the building production capacities in the period starting with the period where we have an up and running production. We're able to go into the pet market, the veterinary market, to monitor glucose for dogs primarily. This will give us the potential to take out revenue while we are continuing our efforts towards achieving a CE mark for the human market.
Let me be very, very clear on this. We are not doing anything. We are not taking any steps or any efforts towards the veterinary market that in any situation will delay our path towards the human market. There should be no question. Our primary target is to get into the human market as quick as possible. We have some opportunities on the way, and we take those opportunities when we see them. We believe strongly that we have a focused and capital-efficient path towards the commercialization. As you see here, we are preparing now to do our pre-CE study, which will be done this year, in addition then also to the actual CE study that we hope to kick off in 2025 so that we can reasonably expect to have a CE mark for the human market in 2026.
Following that, we will do a European launch in the human market in 2027. On this path, we will also do an initial launch in the veterinary market in 2025. We expect to do a full veterinary launch in Europe in 2026 and then continue towards the U.S., both for humans and for pets, preparing from 2027. We have built and are continuing to build a business-to-business model that is partner-driven to enable a scalable and fast ramp-up model. The important building blocks in this model is the fact that our sensor R&D, our design, our production assembly, all are in-house capacities of Lifecare. We are going to be the producer of our product, holding the IP, of course, to all of our technology, while we leave it to our partners to do the sales and marketing.
The first move here will, of course, be to go into a limited launch in the veterinary market, and we're then looking to go into the Nordic market. We believe that we are capable of doing that ourselves, but going from the initial launch in 2025 towards the full-scale veterinary launch in 2026, we are depending on partnerships to follow that timeline, and we are positioned to do so and expect to be able to enter the necessary deals to follow up on the partnership model. Our ambitions in a short-term perspective, meaning within 2030, is to grab a total share of around half a percent of the total CGM target market, meaning that we aim to have 75,000 patients per year from 2030. That will provide us with a $200 million plus annual revenue based on a decent EBITDA margin of 35%.
That was the end statement related to our operational update. As you see here, it's important for us, as we do the progress towards commercialization, that we now are able to actually quantify our outlook and our ambitions. The operational review, as an important part, of course, of our quarterly report, is the fact that we are advancing towards product design freeze and manufacturing readiness. We have a very important collaboration now with TTP, a Cambridge UK-based engineering company that are strengthening our implant design. I want to just comment a bit around this because we have a sensor technology and sensor hardware that has been ready for a long time. The complexity we have seen over the last year is all related to engineering in terms of getting the other pieces to fit into the big puzzle.
As you all know, if you put a piece in the puzzle, if you need to move a piece in the puzzle, you probably also have to move a few more. Actually, to get into a real product, we have done a tremendous job internally to be product-ready, and we have manufactured the first product internally in Lifecare. To be able to go from the first products that we are producing ourselves and into a product that looks like a product in the market, it's been important for us to go together with a player like TTP, as they have developed such products many times before, both within implantable devices and also within continuous glucose monitoring. They are an important engineering player and partner for us. Together with them, we are improving the design.
We have done that to enhance the manufacturability and the consistency of our manufacturing, as already stated. We have validated our new implants already in Q2 in vitro, and we are now just about to put them into the ongoing dog trials so that we are also validating our new implants in the dogs, paving the way for the commercialization later this year. As briefly mentioned, we've also improved our sensitivity. We see now in the lab that our new chemistry showed up to a five-time increase in sensitivity. Early in vivo results in dogs support the lab findings. Of course, a higher sensitivity of the sensor chemistry is expected to improve the accuracy of the CGM going forward. I'm going to repeat myself a bit. Looking forward, I really look forward to update you all on our current state of March.
Hopefully, it will show that we are even more sensitive, but that remains to be seen in terms of the data we will get out from our upcoming studies. The final confirmation on this sensitivity will always require further data and also real-life data. A repetition from previous is the fact that we, in our ongoing studies, have confirmed longevity and biocompatibility in line with what we have promised to the market. We do not see any adverse foreign body responses. All in all, we have a confirmation on durability, safety, and biocompatibility. We are very pleased with the data we are getting out from the studies we have ongoing at the moment. I am going to then leave the word to the CFO and the colleague to do a run-through of the financials.
Thank you, Joacim. Hello and good morning, everyone.
I will walk you through the financials. Let's begin with our profit and loss. We continued with high R&D activity this quarter. As we are now focused on internal development, we have limited revenue from sales of laboratory services. We did not have any grant income this quarter. Due to a disciplined approach to headcount, our employee expenses are relatively stable. Other operating expenses include use of external expertise related to finalizing the implant towards the signed freeze, so that is TTP, as Joacim mentioned. Total operating expenses came to NOK 25 million. This is a decrease from Q4 2024 when we had cost related to the listing on Oslo Stock Exchange. Compared to Q1 2024, the cost has increased due to the ramp-up in production readiness. Overall, we ended the quarter with an operating loss of NOK 25 million in line with our expectations.
We have a net financial income of NOK 4.6 million in the quarter. This mainly reflects the re-evaluation of warrants classified as financial liabilities. This is not a cash gain. Moving to our cash flow, we had a net cash outflow of NOK 21.2 million this quarter. Direct R&D expenses account for approximately 50% of this. CapEx was limited to NOK 1.7 million related to the new production facility in Mainz. We closed the quarter with NOK 40.4 million in cash. The upcoming warrant exercise period, which starts 2nd of June, represents a key funding milestone. We expect that with our lean structure, we will be able to stretch the current and potential funding with the warrants into 2026. This fits our capital use in a strategic context.
Most of our planned spending in 2025 to 2027 is tied to continued R&D in addition to regulatory study and production scale-up. We do not expect any major CapEx this year, but we will see some investments in equipment and machines related to automatic production next year. On the financing side, we are pursuing a balanced strategy. Equity remains our primary source of funding, and we expect to be fully funded with equity into 2026. However, we are also exploring grants and strategic capital. Currently, we do not have any loans or interest-bearing debt in our balance sheet. That was a brief review of the financial. I will give the word back to you, Joacim, who will provide the outlook and the summary. Thank you.
Thank you, Renate. I am not very far from wrapping up the total presentation.
I'm going to remind you to, if you have any questions, feel free to forward them in the system in writing, and we will address them accordingly. The outlook is that we do have a design freeze focused on manufacturability right around the corner, if not already passed. We will continue, of course, to work towards automated and scalable manufacturing. It's an important happening for us in the next quarter that we will take over our new premises in Mainz, where we have planned to move our laboratory and staff, and also our production staff and production equipment to date. We will be ready to take the production from the automated stage today into an increased automated status with the view to ensure scalable manufacturing. If we're going to meet our target of 75,000 patients in 2030, it's obvious that we need to scale up.
Based on our planning, we will have a total manufacturing capacity in 2029 of around 130,000 units annually. From that point, to kind of not let that hang in the air, from that point, meaning 2029, we expect, of course, to then increase further our scalable potential. However, from now to 2029, we have quite some work to do, but that will bring us into a high-volume production at a quite early stage. We will continue our in vivo validation of our new sensor chemistry, in vivo meaning in live tissue, both in animals as we continue our dog trials to validate longevity and biocompatibility, but also through human trials. We are preparing regulatory filings for our final trial to support the CE mark that we aim to start this year.
I think it's worth to mention that we, within a very short time frame, expect to file for our pre-CE study. We want to do a study with a smaller cohort of patients executed quite rapidly. We look forward to update you on that within the next weeks or so. Of course, we are preparing for our veterinary market commercialization that will advance our final product towards the readiness for the human market. In summary, the market we are looking into is driving the next wave of CGM innovations with an enormous addressable market of around $5 billion in North America and in Europe in 2030. We're looking towards a high peak potential of more than $1 billion. On the way to this, we are advancing our product prototypes towards manufacturability as we have planned.
I think that the keyword here is, as we have planned, as what we are presenting today in this quarterly update is, to our understanding, totally in line with what we have notified the market about earlier in our latest quarterly report. The bottom line is that our progress as of now is as planned to in our clear strategy roadmap, where we also have a near-term value inflection point. It's important for us to underline once again, as Renate touched into, that the upcoming warrant period in June represents a key funding milestone for Lifecare. On that basis, we project a financial runway into 2026 based on our lean operational structure and our capital-efficient path towards commercialization. The full report is available for download as usual at lifecare.no at the link presented on the screen right now.
I also want to inform you that our next quarterly report will be held in Bergen on August 20 at the venue Vastland & Probers. That will be at Scandic Bergen Airport together with other stock-listed companies. So anybody located in Bergen or who wants to take a trip to Bergen, you're more than welcome, of course, to join this in person. That concludes our presentation. That concludes Lifecare's quarterly presentation for quarter one for 2025. We are open for questions. The signal I get now is that there are no questions. Given the fact that you can present this in writing, I'm going to give you some more time. If anybody wants to write down a question, feel free to do so. Okay, we are not identifying any progress on the questions.
Hopefully, that is a sign that we gave a complete presentation of the status and no question marks around that. However, I assume that some of you might have some questions that you do not want to, and there is a question. Thank you.
Yeah, we got a couple of questions. We start with the first point. Do you have any feeling about how the reimbursement landscape for implantable CGMs are developing in the U.S.?
That is a very hard question because I think that, first of all, we need to be open on the fact that we have not put any efforts or resources into building understanding of the reimbursement market. The reason for that is basically that the reimbursement market is different from region to region, included in the U.S., where you would see different approaches from state to state.
Given our status as a technology provider, as an R&D company going into product development to do production manufacturing, but with a clear strategy to not do the actual sales, we have not spent the resources that would be necessary to build a firm overview of the reimbursement market. Given the fact that we plan to go with a partner, we would expect that this partner has a far better overview than what we have in that field, and also inputs and overviews in terms of where to go first, which state to go first, which country to go to first, and the price sensitivity in the market. However, I can, of course, speculate a bit around this, given this quite a long disclaimer. For me, it is clear that the reimbursement in the U.S. for implants will grow going forward.
The reason for saying that is the fact that Eversense is already in the market. They do have reimbursement, as they also, to some extent, have had and have in Europe. It is not a new thing. We are coming back to the second mover advantage, to put it that way. Without any deeper knowledge, my expectations based on my market understanding and market insight is that there will be a positive development to our advantage in terms of the reimbursement market, both in the U.S. but also globally. Okay, we have one participant with seven questions.
That is good. One, by which channels or companies will the product be rolled out in the human diabetes market? And what is the strategy for that?
By which companies?
Yeah. Channels or companies.
That remains to be seen, as we have not communicated anything around our partnership progress and efforts.
What I want to say is that the CGM market, the total global CGM market, is dominated by three big American Medtech companies, or to some extent, pharma companies. It's Abbott. It is Dexcom, and it is Medtronic. They hold 99% of the market, of the total global market. The runner-up in this competition is Eversense, the first mover with an implantable CGM. I think that at some point of time, I'm not saying that all patients with diabetes who use a CGM will start to use an implantable because I'm quite convinced that some will be happy with the body worn, with the wearables. Some would rather have an implantable. The fact that we see a quite steep increase in sales from Eversense tells me that there is a quite huge interest out there for implantables with a longevity of half a year or more.
I think that the big players here, Abbott, Dexcom, and Medtronic, have to kind of address the potential that the fastest growing segment within CGMs will have in the future. The second thing is that in addition to these three big players and Eversense, we see a lot of companies coming out of Asia and, to a large extent, from China, but also other Asian players. They all use the same basic technology as Abbott, Dexcom, and Medtronic do with their wearables, meaning that it's a short-term solution with a 10-15 day sensor that is mounted on the body. Obviously, as the big players are focusing on the U.S. and Europe, others are focusing on Asia. Also, the Asian companies are also moving towards the European market. We see that several of them already have a CE mark and are in the market.
Of course, the next step for them will be to go into the U.S. market. As I assume that the big players in the U.S. today will have to address and be aware of the implantable market, I say the same for the Asian market, for the Asian players. I think that within this kind of total scope of already existing competitors, I am convinced that we will be able to find a solid partner that will bring us to market globally.
Second question, what is the status of the agreement with Sanofi?
The status with the agreement with Sanofi is unchanged. We have a product development agreement with Sanofi. It is based on milestones. We, to quite some extent, control the milestones. We have an ongoing open interaction and dialogue with Sanofi based on the principles of the agreement.
Okay, I'll read off the question three and four together. What is Lifecare doing with regard to the lifestyle market? What is Lifecare doing to enter agreements with various companies to various segments of the lifestyle market, including letters of intent, etc.?
I think that we would love to do more to start there. The thing is that for us, it is extremely important to have focus on what we are doing. Our core goal is to get into the market of continuous glucose monitors for patients with diabetes. We have taken one parallel step where we are taking advantage of our position development-wise to bring this into the veterinary market, so continuous glucose monitors for animals, without jeopardizing the timelines that we have in the human market.
For us, it's important to stay focused on those goals because we are a bit reluctant to start on new product developments and new processes that obviously will interfere, given the fact that we are still a limited-sized company, that will interfere in our main path towards the first commercialization. As soon as the first steps into the market have been done, meaning as soon as we start to actually sell in the veterinary market, as soon as we have initiated our CE study, we are very much looking forward to look into not only the type 2, sorry, the type 1 diabetes market and the type 2 insulin-dependent market, but also the rest of the type 2 diabetes patients that are not depending on insulin treatment, and also the patients that we define as prediabetes. Just to give some numbers around this, right?
There are 600 million people in the world with diabetes. 110 million of these are insulin-dependent as type 1 or type 2. The remaining part, the lion's share of the type 2 diabetes patients, but also what we define as prediabetes, is far beyond those numbers, meaning that we have even more than the total number of diabetes patients because we include the prediabetes patients, meaning that we might turn the number of a billion people that could have use of our technology. Kind of starting to play with these numbers is a very good reason to defocus. Hence, we do not want to do it at this point of time. I still have not kind of entered the potential for the lifestyle segment, right?
All humans on Earth with an interest in monitoring their glucose, whether it is of dietary needs, lifestyle needs just for the fun of it, whether it is related to sports, whether it might be related to other diseases. Yes, this is an enormous market. For us, it is very important to stay focused on our core goal, which is to commercialize Lifecare's technology from the top and down in the diabetes market.
That also mostly summarized question five and six. Why is Lifecare not focusing more on the lifestyle market? And six, why is Lifecare not being much more specific and detailed with regards to the lifestyle market and its opportunities? I believe that I have addressed those questions already, yes. Question seven, 75,000 users by 2030 seems extremely low. If you have good partners, this number should be much higher.
Please explain this low estimate.
I think that there are numerous reasons to have a reachable goal. First of all, in this setting, where we have a quarterly presentation, I think from our perspective, we want to provide outlooks that are reasonable in an investor perspective. I think that it's very easy to kind of deviate from the focused thinking and to kind of be impressed by the total market size. Hence, to then continue to just let the finance people and Renate, she could do a lot of calculations based on the fact that this is an addressable market of $30 billion in 2030 US dollars. To build a company, to build a production, to build a product is somewhat a detailed endeavor. It is not done, I mean, we are not putting up a sign and selling hamburgers on a corner.
We have regulatory affairs affecting both our organization, affecting our product, affecting our production, affecting our distribution. To assume that we will go from zero to 100,000 within a couple of years is an intriguing thought, but I'm not sure it's very realistic. Given the fact that we have balanced both the fact that we are building up our company with production, etc., going forward, we are looking towards a reasonable scaled manufacturing capacity. I think that this is still quite a tough number to reach within five years. We aim to do it, and I hope to be able to confirm this in five years that we actually met that target. Manufacturing-wise, we will be ready to do it. There are also challenges related to how to distribute this and how to get it out there to the users.
To grab 0.5% of this market seems very low. You can say that 75,000 patients seems very low. Realistically, it is a quite tough goal to reach. It is the starting point of this. I also want to add, we cannot expect to be welcomed into this market with open arms. We assume that we represent a financial threat to the existing players in the market. Hence, they will do what they can to keep us on as much distance as possible. What we have seen in this market over the last years in the European market is that especially Abbott, but also some of the other players, have been quite hard on litigations towards the new technologies or the new companies coming from Asia.
There is also kind of a strategic approach to this that we need to take into consideration when we formulate our short-term goals. As much as I would meet you on that question and say that you're right, it should be $2 million annually, I want to stay on what we have identified as a reasonable approach, yet high revenue potential.
Okay. New participant questions. What do you believe will be the major driver for the implantable CGMs to gain traction over the current CGMs?
I think that the main driver is the potential to have a longevity, to not have to change and swap your sensor every 10-14 days.
Alongside that driver, I think that the reduced visibility, so the inject-and-forget approach, is important, not only in the terms of what the surroundings will see, whether you have diabetes or not when you have a wearable, but also for the user to be able to inject the implant and not be kind of reminded of the disease visually all day. Kind of those two drivers, I believe, are very important. I think it is also worth to add here that from our perspective, based on our expectations on sensitivity, hence with reference to our increased sensitivity of chemistry, of course, from a medical perspective, both for the clinicians but also for the users, if we are able to, as we believe we are, able to show a better sensitivity than our competitors, that will, of course, also be potentially a huge driver. Okay.
Another participant asked if you could please say something about the technical challenges related to inserting such an implant under human skin.
Yeah. I mean, other than the fact that this is something we need to do, we do not think that to inject it under the skin has any kind of adverse serious challenges. We are developing an injector that is easy to use. The prototype is already ready, and we expect to start to use our injector within not too long in our trials. Of course, every time you put something under the skin, you would have to be aware of the body reaction. So far, all of our data show us that we do not have any unexpected body reactions. There is no inflammation. We are, of course, checking this with biopsies and also with visual observations.
There is, of course, you would always, when you put something under the skin, you would have potentially issues with migration, that it might move from where you implanted it. We are taking the measures that we find appropriate to actually meet that as a challenge. Of course, to sum this up, there will always be challenges when we kind of play around with the human body. We are not the first implantable device. There are loads of passive implantable devices, also to an increased degree active implantables as we have. There is quite a lot of knowledge around this in the product development perspective and also in the medical perspective. We do not see any specific issues for Lifecare in that respect. Okay. A new participant asked if why is it easier to make implants for dogs than for humans? It is not.
It's not easier to make the implants for dogs than for humans. It's basically the same setup. We are taking our human product, and we are going to implement it in the veterinary field. However, the relief in that area is the fact that the regulatory complexity is far easier to approach than what it is in the human side. On the human side, we have to do a quite big study, somewhere between 100 and 300 patients. We have to build a technical file where we are able to defend all of our claims to be able to get a CE mark. This is not the case in the veterinary field. In the veterinary field, we have to, of course, have a CE-approved electronics. That is based on every electronic product needs to be CE-approved.
There is no specific medical requirement other than a consideration from the veterinary that this is safe. Of course, we are approaching this as we are doing the veterinary as a parallel run to the human. We are, of course, taking into account the same safety precautions, etc., for the veterinary field as we do in the human field. We do not have to have the same degree of regulatory awareness, to put it that way. Hence, it is an easier, it is a low-hanging fruit, and it is a short-term reflection point in terms of revenue.
Last incoming question. Have Lifecare received any interest from companies interested in licensing or buying technology rights for specific markets or areas of use?
I assume that is a question related to other users than glucose, but let's also conclude within glucose then.
Yes, to the extent we do have a product development agreement with Sanofi where they have a first right of refusal of a global license to our technology. Of course, we are in dialogue with other companies, both in the human and the veterinary field. The dialogues we are involved in are, of course, based on a mutual interest to see how we can work together in the future. The answer related to glucose measurements, our core goal, yes, we are facing interest. On the other side, when it comes to other analytes, so other biomarkers than glucose, we have no focus on it at the moment. This is just to follow up what I said, that we do not want to go into the lifestyle segment before we go into the medical segment of glucose.
The same goes for the potential we have on a platform approach to measure other substrates than glucose. We are not doing any actively in that field because we are focusing on doing our commercialization as we have planned it. That seems to be the last question. I want to close this session by saying that you are free to contact me or any other members of the Lifecare team if you have a question. Feel free to forward it. If you formulate the question, I promise that we will also reply to that question. Other than that, I hope to see you at our next quarterly presentation in Bergen, the 20th of August, at Vastaana Hobers. Thank you very much for your participation and interest. Have a good summer.