Thank you. I appreciate the opening remarks, and I will share my presentation. Just one moment. OK. Thank you, everybody, for attending. I'd like to share with you what we're doing at GlucoTrack and how we're working towards advancing diabetes management. We're a publicly traded company under NASDAQ, so these are our typical disclaimers. GlucoTrack, what we're trying to do and working diligently toward is bringing a new type of continuous blood glucose monitor to the market. You may be familiar with those patients who have diabetes, who wear a device on the back of their arm, a small device about the size of a quarter. They use those to measure their blood sugars. They're great devices. They work well, but they don't work for everybody. They also have some challenges, and we'll talk about that.
What we're working on is a fully implantable continuous blood glucose monitor that lasts for a much longer time, as well as it measures glucose in the blood as opposed to under the skin or in the interstitial fluid. The big advantage here is that it takes away the burden of the wearables from the patients. As I mentioned, the differentiating feature primarily is the ability to not have anything on body. Of course, in addition, it can be viewed as a set it and forget it. The device is implanted once, and it lasts for three years. There's no need to worry about getting a new product over that time, worrying about insurance renewals or so forth. There's a lot of benefits for the patient to reduce the burden that they have with managing their disease or, in particular, managing devices so that they can manage their disease.
The CGM market is quite large, and it's still growing double digits. It finished last year at $11.6 billion in revenues. Yet, in the U.S., it's still only about 50% penetrated. It seems to be, unfortunately, leveling out and with some challenges in trying to get the remaining half of the patients to use the products. This is despite broad reimbursement that's available for these products, as well as, of course, the high level of comorbidities that diabetes has with other issues, particularly cardiovascular, renal, and so forth. At GlucoTrack, as I mentioned, we're working on this fully implantable version. We've already entered into the clinical phase. We had an OUS, first-in-human study, completed earlier this year. It was a short-term study to evaluate primarily the safety of the product, with a little peek into the efficacy or accuracy of the measurements.
We completed that study safely and with no issues, and with a good initial look at accuracy. We also are starting another OUS study, this one in Australia, to have our fully implanted system for at least a year in patients. We look forward to that data coming from that study in the near future. In parallel, we've engaged with the FDA on an IDE study to effectively repeat the OUS study in the U.S. and with a bit more patients. We're targeting approval by the end of the year and starting that trial sometime in later Q1 of next year. This will be on towards the Atenovo 510(k) regulatory pathway. Of course, we have our ISO 13485 certification for the appropriate quality and regulatory readiness necessary to do these studies.
One of the things I believe is quite unique about our team is we have a very seasoned team in continuous glucose sensing, as well as in cardiovascular and implantable devices. This is the confluence of all three of those, which I'll get into a little more detail in a few minutes. Each of these players have worked in at least one of those fields, if not more, and worked on multiple generations of product. It's a very, very, I would say, mature team that understands the space very well.
Sorry, Mr. Paul. Sorry for bothering you. I think the presentation is not moving or your slides.
They are. Yes, they sure are.
They are not moving on our end.
OK, let's see.
OK.
I took them out of presentation mode. Do you see them now?
Yes, we are now on continuous page. Is that correct?
That is the current page. Yes.
OK.
Prior to that, you were on, I would presume, stuck at this page?
Yes.
OK. All right. I'll go real briefly. Thank you for letting me know. I'll keep it in this mode. Our disclaimers, again, the goal of the company, which I'll get into a little bit more as we project through the slides. We have a very differentiated product in a very large and growing market. We've already entered the clinical stage and have more work forthcoming in the near term in those efforts. This is our team, as I was talking to just moments ago about the team. Now we are caught up on our slides. As I mentioned earlier, the CGM market is quite large, growing in double digits. Finished last year, $11.6 billion in revenues. You can see here the quarterly revenues in the last 20 years. There was a bit of a hockey stick around 2017. It's no surprise there.
That's when, in the U.S., reimbursement became available for these products. What's interesting is you see that 50% of the revenue consistently, quarter over quarter, 50% comes from the U.S. and 50% OUS. Most of that being in the EU space. Still, it's a good 50/50 split, U.S. and OUS. Moving forward in this presentation, we'll focus more on the U.S. population. Here, as you can see, the potential users for CGM are type 1 and type 2 diabetes patients. You have many subcategories within the type 2 realm. Type 1 is the immunological disorder. Type 2 is largely, but not always, driven by diet and exercise, or maybe insufficient diet and exercise, let's say. You can see the rate of penetration in each of these markets. These are penetration in type 1 and type 2 insulin-intensive, those who need insulin as much as type 1 patients.
Type 2 basal are those who just use a regular delivery of insulin and not as intensive. Type 2 hyper-risk are those patients who don't necessarily need insulin but are at risk of falling very low blood sugars. The remainder of the type 2 group, which is the largest by far. Typically, once a person has type 2 diabetes, if they don't manage their condition, they will migrate typically from the non-insulin to the basal insulin and then to the insulin-intensive. One might ask, you know, why is there such a lack of penetration into this market despite the growth and the reimbursement? When you look at the current products, they're great products. They have great attributes. Some of the attributes also have shortcomings. One of the big benefits is that the sensors are wearable, so patients get 24/7 data.
The cost of wearing them is there's an adhesive that sticks to the skin. Sometimes it falls off. Sometimes it's uncomfortable. Some patients, it causes a rash or itching. There are some challenges there. Some patients don't like their sensors to be seen. There are some challenges in that regard. Another attribute is the sensors, they initially came out lasting three days. Now they're lasting 15 days, which is phenomenal progress. Yet, still, every 15 days, a patient has to do a replacement and ordering supplies. If they're going away, they need to bring in an extra sensor with them, or depending on how long they're going, maybe a couple of sensors. There are those concerns that the patient has to manage around it. Also, like I mentioned earlier, this is a continuous measurement. They're measuring glucose levels continuously, 24/7 in the interstitial space, which is just under the skin.
The problem there is that during times of rapid glucose change, there can be a delay relative to the blood glucose by about 15, up to 15 minutes. You may say, when is that important? It's when you're eating or exercising or when a patient is sick or under stress. Those are when the glucose levels can change rather quickly. As you can imagine, especially with eating and exercise, that can happen multiple times a day. Dosing with insulin or with the sugars, if the blood sugars go low, knowing sooner is definitely very valuable in those times. Of course, there's great broad reimbursement coverage for the CGMs. Unfortunately, it's a product that has to be managed. There's a supply that has to come, usually shipped in three months or sometimes six months' worth of products shipped to a patient. There are also reauthorizations that are required every six months.
It used to be every three months until recently. There is that aspect, both for the patient and the physician, to deal with. When you look at CGM wearers and those who use CGM and what they think is needed, you go back when this is an external market research done on CGM users by a firm. They've done this survey for many years. We asked them to go back and look at 2018, which was the year after reimbursement coverage. They always ask it every year, several questions. One of them is, what's needed? What's important that is not there? You can see here that in 2018, as well as just last year, the same top six come to the list. This is over thousands of CGM users.
Despite the current manufacturers actually making good progress in most of these areas, they still seem to be at the top of the mind of patients as something they would like to see better. Five out of these six items have to do, in one way or the other, with the fact that the device is a wearable. That is where we come in. We figure we could solve the wearable problem by going implantable. How do we do that? Going implantable, of course, one could always think there is extra risk and a new procedure and new materials and so forth. We decided to de-risk the technology, de-risk the materials, de-risk the clinical approach, de-risk the regulatory approach by leveraging tried and true and mature technologies that are used currently in the cardiovascular space. Insertable loop recorders are used.
Patients have those implanted under their skin for up to three years. You can see here on the left such a device. Our device is very similar to that, our electronics. Also, many people have pacemakers implanted with a lead going all the way down into the heart through the vessel. Our device is similar in that we have a lead, but the lead does not go down into the heart. There is only one, as opposed to two or three, depending on what type of pacemaker is being used. Our chemistry is very similar to the chemistry that is used from conventional CGMs. By taking these three pillars of very mature technologies and standing on the shoulders of those giants and merging them together, we have come up with our particular design for an implantable continuous glucose sensor. One might think, OK, who would be implanting this?
Where does the patient go for this? Because the device leverages so much of the cardiovascular technology, it is natural to think that the proper person to implant that would be one who implants those other devices, like insertable loop recorders and cardiac pacemakers. When you look at the comorbidities that patients with diabetes have, you see that there is a large overlap with cardiovascular risk. As a result, these patients, in large part, are already seeing a lot of cardiologists on a regular basis, whether they are a patient with type 1 diabetes or a patient with type 2 diabetes. Those referral patterns are in place. Those physicians, those cardiologists, of course, are also sometimes managing these patients already. In some cases, referring back to endocrinologists because of a lot of the drugs, like the GLP-1s and the SGLT-2s. Cardiologists are prescribing them for cardiac reasons as well.
Of course, just the comorbidities of high blood pressure and arrhythmias, coronary artery disease, and so forth. To boil down, really, the value proposition of our product is that we have a fully implantable device with no on-body wearable. The signal goes straight from the implant to one's smartphone, and the device lasts for three years. I believe that this gives patients a lot of freedom. They don't have to worry about constantly managing their devices, worrying if they need to take the device off because they want to go to the beach and they're losing the last three days that that 15-day sensor can provide them. What do they do in the meantime? That is the real unique value proposition that we have, to give them their freedom back without having to worry about managing the device so they can live their life.
Further to that, we're also measuring, as I mentioned before, in the blood, as opposed to the interstitial fluid. We overcome the lag time in critical times of rapid glucose change, which can happen multiple times a day. Our target populations, this is sort of a subset of what we saw before. If you recall, there were five columns. The fifth column was the non-insulin-dependent type 2 patients, which was 25 million. This is our subset. These are all currently insured in the U.S. with CMS coverage to be able to get a CGM. You can see down below the penetration rate with current CGM products.
Looking at our overall market in terms of segments, when you look at the cohort size, as you can see there is reflected from the previous slide, our target segments are based upon market research data we did on existing CGM users and non-users and to do with a very detailed analysis to understand which of these patients would be likely to actually consider having an implantable, as opposed to continuing to wear the existing product or to migrate from not wearing that product to having an implant. Our data suggests that roughly about 30%, a little bit more type 1s than type 2s, but roughly about 30% of the target market would be likely to consider the device. At the end, we believe our serviceable market is about 3 million patients. I mentioned earlier in the talk that we did some study.
We did a first OUS short-term clinical study. We did this in São Paulo, Brazil, at the very, very prestigious cardiovascular institute there called Instituto do Coração (InCor). Here, you can see we did six patients that had diabetes. Primarily, at the top is an example of how we compare against a reference standard. We also had the patients wear a conventional sensor. You can see the bottom left, the orange dots are us, and the blue dots are the conventional sensor. You can see that we're basically very much aligned, very similar to them. The little graph, the colored graph on the right, is a diabetes-related, diabetes society-related graph to talk about safety of points and so forth. All of our measured points and calculated points are in the safe region. No bad effects and good accuracy.
In terms of overall clinical and regulatory timeline, like I said, we're starting an OUS study in Melbourne, Australia, a dual-center trial that is starting this quarter. We look to have data from that in the near future. In the meantime, we're also talking with the U.S. FDA about an Investigational Device Exemption (IDE) study. From there, we would launch the IDE study, that pilot study, early next year. By 2027, both the OUS study and that study will be complete. We'll be well into a pivotal trial by that point with potential commercial approval in later 2028 and launch near the end of that year. Again, just a brief highlight here.
We think that we have a lot of strong market tailwinds. The continuous blood glucose monitor (CGM) is very well established, mature, known in the industry, reimbursed, and still continues to be fueled by new technologies such as GLP-1s and automated insulin delivery, combining it with pumps. Yet, about half the patients with diabetes who can use the product and are reimbursed for the product in the U.S. are not using it. We think we've really de-risked this from a clinical and regulatory technical standpoint by using tried and true technologies and look forward to bringing this product to those patients who can't or won't use CGM. Thank you very much.
All right. Thank you, Paul. If anyone has questions, please feel free to type your questions into the Q&A box. Paul will address them now.
Looking at the questions, how does the GlucoTrack system differ from current CGM technologies? Primarily, I would say a couple of major differentiations. One is that it's a fully implantable system. All but one of the current products are non-implantable, so we have no on-body wearable. The one device that is implantable, as of today, still requires an external wearable, and it also lasts only one year. Excuse me. We're working to last three years. One question is long-term patient studies would start in Q3. Here we go. We are still working towards that. We do expect that the studies will be moving forward later this quarter, and we're excited about that happening. We do have regulatory approval in Australia to start that trial. Any updates with the Forget Diabetes partnership? We did do the study with Forget Diabetes.
We were a partner in that, and it was a single animal study, one animal study, I should say, with two animals in the study. We're not the ones controlling the dissemination of that particular news and outcome, so we leave that to the principal investigator and their team to make that information public before we say anything to that effect. The question is, what key inflection points can investors anticipate over the next 12 months? We would see over the next 12 months the early readout of the OUS study in Australia would be one of those. We would also hopefully see the IDE approval. We've already initiated, like I said, the pre-sub process with the FDA, and we've worked towards what that protocol looks like.
We understand what they expect to see, and we're refining that and look forward to getting approval for that study by the end of the year, if all goes well. The FDA has been really good to work with thus far, and we don't expect that to change. Of course, they've been great. That's another one. We will continue reading out on the Australia data, sort of like a month one and a month three and a month six and so forth. That study is going to be up to 30 patients in two centers. We'll have a similar readout for the U.S. study when that starts, and that one, we're targeting three centers in the U.S., up to 40 patients. We expect to have readouts there on that study. As I talked about, 12 months.
Further down the road, we will be eventually also submitting for a larger scale IDE pivotal type trial for commercial approval in the U.S. That effort will start much later next year in terms of those submission activities and discussions with the agency. We should also have some nice podium presentations and papers that should be coming out on this data as well. Another question, what is your estimated TAM? Which patient populations are you targeting? What are the unmet needs within this group? Our total addressable market is the 10.7 million patients with type 1 or type 2 that need insulin or are at severe hypoglycemic risk. Those are the patient populations that we're presently targeting; that would be our total addressable market.
Out of that, looking at the psychographics and the market analysis of those types of patients on a survey we did of over 800 patients, CGM users, we believe that about 30% of those would fit the profile to be candidates. From that, we're down to about 3 million, which would be our addressable market. Obviously, from there, how many will decide to actually get the product? That number can be fluid based upon early reporting of what we have from our clinical data. If we're successful in hitting the accuracy goals and longevity goals that we're targeting, we expect that number will be definitely on the higher side. Another question is, what is the projected capital to bring the CGM through clinical trials or regulatory approval? We expect that to be roughly about $20 million a year, maybe a little bit more, let's say $20 to $25 million.
Again, we're targeting commercial approval in a little over three years, which is what our goals are. You can target $60 to $75 million at this point, which we think we need to get to commercial approval. One last question, what are the key technological innovations for the product? I would say it's not necessarily that we're creating new technology. The sensor technology is similar to that used by others in the CGM space. We're just extending its life much longer. The actual device itself is very similar to cardiovascular devices. We're not necessarily creating any new technology, so we can de-risk that aspect and also de-risk the implant aspect and de-risk the regulatory aspect. Combining all those together is maybe what makes this approach a little bit more unique and interesting because it is relatively de-risked from those perspectives. I don't see any more questions.
I would like to thank everybody for your time and your interest, and for your very nice questions.
All right. Thank you so much, Paul, for the wonderful session. Thank you to everyone joining here today. You have a wonderful day.
Thank you. Have a good day. Bye.
Concludes GlucoTrack Inc.'s presentation. You may now disconnect. For details and upcoming presentations, please refer to the conference agenda. Thank you for your participation. We look forward to welcoming you to the next session.