Interface at the bottom of your screen. With that, Tim, I'll turn it over to you.
Great. Thanks, Alex. Appreciate the time. Appreciate the opportunity for everybody joining us today. As Alex said, my name is Tim Goodnow. I am the CEO for Senseonics. Senseonics is a technology company that is focused in the area of long-term continuous glucose monitoring products for people with diabetes. Our mission is to do exactly that, is to use technology and enable the lives of the unfortunately significant expansion that we've seen over the last couple of decades of people with diabetes. What history has shown for sure is with the introduction of new technology for diabetes management, those people that bring out high-quality medical devices that can help people manage it, and they are viewed as attractive and value-adding products, we'll certainly see that there is your large utilization of the technology. Eversense certainly aims to be one of those in this large, today, almost $15 billion market.
Senseonics has actually quite a history of developing technology, regulatory approvals. It began with the launch of our 90-day product, where we did receive FDA approval under the panel track. So we received our PMA back in 2016 and developed a number of innovations along the way. We are currently selling the six-month configuration of the product. So it lasts for 180 days and we also have not only approval here in the United States, but also approval under the CE marking for commercialization in a number of other markets. Most importantly, right now, we are at a very transformational point for the business with our technology in that we are just in the approval process. So we have submitted for our 365-day product, so one year under the ICGM designation, which we can talk more about. What is the market we're participating in?
As I see, we're predicted to be just about a $15 billion market next year. We are growing at actually a little bit closer to 25%. It's the most recent numbers that I've seen. And that's really driven by the recognition in the payer market. So those are the commercial payers as well as Medicare, that continued expansion of the people that can be treated with CGM continues to grow. In the United States, essentially, if you are on insulin, whether that's once a day, multiple shots a day, or even on an insulin pump, then these payers will remunerate for putting people on CGM. As I said, it's somewhere between $12 billion-$15 billion in the next couple of years, growing at a very rapid pace as more and more people move to the product.
Currently, a little bit over half of the people with Type 1 Diabetes shown on the left are currently using CGM. It is the first market that moved or subsection in the market that moved. Those that have the most need for continuous glucose monitoring, specifically around alarms and alerts, especially at night, to wake them up in advance before they get too low, before they get too high, so that they can take action. There's about 2 million folks, and a little bit over half of that population is currently penetrated. In addition, there's another couple of million, 2.5 million folks that are on type 2, that have Type 2 Diabetes, that are on what's called MDI. So those are multiple daily insulin shots. That is the most active form of the type 2.
As it advances and you become more and more insulin resistant, you tend to be treated with the need for more and more shots over time. And to keep your glucose regulated and low, you'll get more aggressive with the insulin shots. But at the same time, you don't want to go too low into hypoglycemia, which is a cognitive function impact, enhancing the need for the continuous glucose monitoring to keep you in a pretty tight normal range. Importantly, over the last year, approximately, there has now been support, reimbursement support for what's called the basal insulin. Those are the folks that have type 2 diabetes, but they only give themselves the background basal insulin with one shot a day. And as you can see, there's very low penetration into that market of only about 10%.
And the other group that has availability for reimbursement is those that have hypoglycemia risk. And there's even smaller reimbursement in that. So as you can see, CGM has been an exciting product. There's about 4 million folks in the United States that are candidates for CGM until the last year, where that market has more than doubled. So penetration overall, just about 25%. So big opportunity for further growth, as well as differentiation with the different technologies. And when you do ask people what they're looking for, this is really the basis of where we are and where we're headed as a company. People that are on CGMs or not yet gone on to CGM, they are really interested in two different things. One, you want to make the sensors to last longer. And why do you want to do that?
Because you want to spend less time managing your devices, less time thinking about your diabetes. If you can use technology and automation to do that, it really is, of course, to your advantage. In SenseAware, longevity is one of the things that's currently one of the biggest issues that they deal with. The devices are labeled for 7, 10, or 14 days. Frankly, a significant portion, a third, 40% of those sensors actually don't survive to that end of life. They're constantly changing out new sensors. They're taped with adhesive to the body. Managing that when you shower, when you want to swim, or you're exercising is a real consideration. If we can simplify that for them, you're going to really see a lot of people move to those products, which is what we focused on on duration.
Then for those that haven't gone to it, there's approximately 75% of the market that is available, but they haven't gone to it yet. The number one thing that they're looking for is they don't want to have anything attached to the skin. So I'll talk about what we're doing as we move forward with technologies to eliminate any on-body skin component as well. Our current Eversense product is shown here on the slide. There's a very small, it's 3 millimeters by 16 millimeters long. It goes in the back of the arm between the shoulder and the elbow, so completely out of the way. It's placed there by the medical professional, whether that's a nurse practitioner or an MD. It's done in a simple doctor's office procedure, small preparation, clean the area. We provide a small amount of lidocaine is given.
Then with a tool that we provide, it's delivered just under the skin. It's down about 3-5 millimeters, stays under the surface. It's a highly accurate device, meets the accuracy requirements for the iCGM designation, which is an opportunity to provide interoperability with different insulin pumps that are out there with that partnership. And therefore, especially with Type 1 Diabetes, do automated insulin delivery based on your glucose levels. So at high glucose levels, you'll deliver more insulin. At very low glucose levels, you'll actually turn it off in an autonomous mode, which is really attractive to people with Type 1 Diabetes. Not really a market for Type 2 Diabetes because of the difference in the disease state. But if you're with Type 1 and you don't produce any insulin, it's a great alternative for you.
Currently, in our current generation, we do have a transmitter that's worn above it. It provides the powering to the sensor through near-field technology and Bluetooth technology to the smartphones that the people use for the large interface and the communication to the cloud and to your healthcare provider once you're in cellular or Wi-Fi range. In addition, we're also launching a remote patient monitoring solution. This is first implementation with a partnership we've recently announced with Mercy. What this will be is a focus on those Type 2 patients that don't frequently see the high diabetology offices like you see with Type 1 patients. What we're really looking for here with Mercy is an opportunity for us to do prospective monitoring of at-risk patients, diabetes patients that tend to be the most expensive.
So this is a typical accountable care organization, and they're looking for methodologies and tools where they can identify the biggest at-risk patients, get them managed, get them monitored ahead of time before they show up in the emergency room and get really costly for the healthcare system. So we're interested to bring that. This will be a nursing review of data from Eversense and then a triage based on medical rules that are set up with our partner with Mercy and identify those patients that they're at highest risk right through their system, which in their case happens to be the Epic hospital system, and notification to the primary caregiver that they should triage those patients and should see them so that they could take action. Who are the patients that use? And there are about 5,000 patients that are currently on Eversense.
About 30% of them, when they come to us, they're actually new to CGM. So they've made the choice to come on because of the long-term nature of it. About 70% are actually switching from one of the other devices. In regards to who are the most typical type of patients, we do get asked that question. But quite frankly, because of the attributes, you see a pretty equivalent distribution of patients, whether they be in the younger populations, which tend to look for more flexibility, the ability to take the transmitter on and off, which you can do with an implanted product that you can't do with one of the other existing transcutaneous products.
Or in the Medicare population, the older folks, they really see a lot of value in placing and having the medical professional actually place the sensor so they don't have to do it in the home setting. We are seeing the most growth in that Medicare population with about 60% of our patients today growing quite rapidly are type 2, with 30% as type 1 diabetes. Economics in regards to reimbursement, there is broad-based reimbursement for Eversense. There's about 300 million covered lives in the United States, obviously, including all of the major commercial payers as well as Medicare. Reimbursement tends to be because of the varying length of the different sensors. They said they range from a short of 7-14 days for the other three manufacturers and currently 180 days for Eversense. They reimburse at just about $10 per day.
So for a two-week sensor, they'll typically reimburse you $140, whereas the 180-day sensor will be reimbursed about $1,800. Commercialization is done with a partner organization, a company called Ascensia Diabetes Care. They are the former Bayer Diagnostics. It's long-term. They've been around for a number of years and currently today do about $800 million, maybe a little bit less in regards to strip and meter. So this is the traditional prick your finger, get a small drop of blood, and measure a single point in time glucose reading. They recognize that that market is changing. A lot of pricing pressure and utilization is down because there is so much growth in the CGM space. So they're looking for a CGM partner. Eversense has been a great product for them.
Our partnership is one where we share the revenue that's generated with the vast majority of that currently coming to Senseonics and a portion going to Ascensia. They cover all of their investments and have responsibility for all the commercial activities, such as the dedicated sales force, the infrastructure for distribution, commercial distribution, as well as the marketing of the program as well. There are currently 25 reps that are dedicated in the United States, and there's a shared sales force for their strip and meter business in Europe. In addition, we have a partnership with a nurse practitioner group. This is for the insertion. So it can either be done in the doctor's office by the prescriber, the medical professional that currently is treating your diabetes. If they are not certified to do it, there is a nurse in the area through the inserter network.
These are nurse practitioners that have authorization to do the insertion. And they will actually either come to your house or come to the office and actually do the insertion for you. So we're looking to build the flexibility to expand on the number of folks that have the capability to do the insertions of the Eversense product, as I said, doctor's office or even in your home. In addition, we recently announced a partnership with Mercy. It is a large top 20 hospital system. This is Midwest-based out of St. Louis. They have about 3 million patients that they serve. And specifically, they have about 30,000 patients that they would like to put on CGM. And they have specifically selected Eversense. What they're looking to do is this is an ACO, an accountable care organization that shares risk.
For that, they get access to a number of patients. What they'd like to be able to do is use the long-term Eversense, initially with six months, transitioning to the one-year product when it's available, to monitor those patients. As I said, we'll use the remote patient monitoring managed technology to identify those that are the highest risk, report those through the AI analytics that are developed with the Mercy medical professionals, integrate that into Epic, and report it back out to the primary provider who can then adjust therapy, lifestyle, or other issues that are managing their diabetes. Our partner Ascensia has responsibility for the commercial activities and has focused very significantly on the direct-to-patient component as well. The sales professionals, of course, sell to the doctor's offices and do an education introduction.
But also because diabetes is so large, there's quite a bit of consumer-led advertising as well. We follow all the traditional approaches, whether that's linear televisions. We've done test markets with that, quite a bit of connected TV, and of course, a lot in paid social media as well. You can see us on Instagram, YouTube, TikTok, and a lot on Facebook. So where are we headed? This is the primary responsibility. As I said, Senseonics has responsibility for design and development. We are just about a couple of months away from launching our one-year product. This will be the basis for all of our future designs going forward. The doctor will place that or the nurse will place that, and you'll wear that for a full year.
Return a year later, that small sensor that's shown in the photograph is then replaced, and you begin the next one-year cycle. So great compliance when you place the sensor. Obviously, it's going to be there for the entire year and access to one full year's worth of data. Shown in the top bar is the current product that we are currently selling with the Ascensia partnership that is available. As I said, we have almost 5,000 patients that are on the product. About half of those are in the United States. And we currently anticipate sunsetting that product later in 2024 and replacing it with the one shown below. That's a 365-day product, which is currently under approval review with the Food and Drug Administration as a 510(k), which happens with the iCGM designation. And then after that is our next two-generation products. The first is Gemini.
It's really dedicated to be a bifurcated product in that we will continue to offer a continuous glucose monitor for those people with type 1 diabetes. They really do need to think about it as really the nighttime recognition and alarms and alerts that you'll need with somebody that's very dependent on the appropriate insulin levels. We'll be able to provide that with the existing transmitter and self-powered sensor, but also have a second design, which is more targeted towards the much larger type 2 population, which is a standalone product. Because we've incorporated a battery into this technology, it will actually collect all your glucose 24/7. And then on demand, when you swipe it with your phone, you'll be able to recover the last eight hours' worth of glucose data. So this is a great advancement of the technology for the majority of our patients.
You'll actually have no transmitter. You'll have nothing on the skin, but the ability to recover continuous glucose anytime you want, whether that's three times a day to get 24 hours or 30 times a day if you want to really interrogate where you are. It's a great alternative. This product is actively in research, and we anticipate here in the coming quarter putting this forward for our first human clinical testing. So we're excited about bringing this next-generation product out in 2025 and beyond. And then finally is our Freedom system. It is the ultimate. So it's a combination of the 1-year technology that we are just getting product for, the battery incorporation that we talked about with the Gemini product, and then finally, ultimately, incorporation of low-energy Bluetooth.
So this sensor itself will go right to a phone, give you the real-time results, the overnight protection that we talked about directly to your phone. So this is the all-encompassing solution for type 1 and type 2 diabetes. Nothing on the skin, complete freedom from having any appearance and full discretion that you don't have any diabetes technology strapped to your body. So we're excited about it. It's a big part of our innovation. Just to wrap up very briefly on the balance sheet, we did in the last quarter with just about $100 million in cash. We do have debt in the form of a convertible note as well as a debt partnership with Hercules Capital. And we do spend about approximately $5.5 million a month. We've given revenue guidance for the first half of the year.
We'll be updating that actually next weekend at the ADA meeting as we've launched this partnership with Mercy, and we get good recognition for their revenue as we launch the new opportunity with them in the fourth quarter of this year. So with that, we'll stop and take any questions that we may have. Great.
Thank you very much, Tim. Maybe we could start with the Gemini and Freedom that you just touched on. Could you tell us a little bit about the timeline for those and the approval processes kind of relative to what you've gone through already?
Yeah. So the next step for us is the Gemini product. As I said, we'll be doing first-in-human testing in the near future.
We anticipate that we would be running the pivotal trial in 2025, and we certainly would like to have that product available in 2026, so a little bit over a year from now, commercially available. The regulatory approach for that will be, quite frankly, under the 510(k) scenario as we now have the iCGM designation. So that's a 90-day review time period. The clinical testing for it, we are still to work out, but we'll likely be targeting a comparator against the standalone product that we will commercialize for 365 with the on-body transmitter versus the other configuration without the on-body transmitter with the swipe interrogation. The Freedom product is behind that, is likely a year further behind that. We haven't formally announced dates for that because we're still in the research phase of incorporating that low-energy Bluetooth inside the implanted sensor.
Great. Yeah. Thank you for clarifying.
And for folks a bit newer to the space, could you tell us about CGMs and how they enable remote patient monitoring, what you touched on, but maybe why that's such an exciting space for payers and providers? Yeah. I mean, it's exciting for a couple of reasons. One, traditional treatment of diabetes has honestly been just during your doctor's visit, right? You come in, maybe if you're highly compliant type 1, you're seeing your doctor twice a year. If you're, unfortunately, a garden variety type 2, you may not even be going once a year, right? So the doctor is going to look at your current blood test, single point. They may review some logs if you bring them in, not very typical, and they'll make therapy recommendations based on that. That all changes with remote patient monitoring, continuous glucose monitoring.
So you get a new glucose result every five minutes, right? Because of the incorporation of that on the phone, that, of course, is all pushed to the cloud and the doctor can see it. So we have a series of standardized reports that we'll run that'll tell you what your frequency, how often are you going really high on blood sugar, how often are you going low, and how much time are you spending time in range, right? If you don't have diabetes, you spend 100% of your time in the normal range, of course, by definition. As your disease progresses, it can get as low as 30% or 40% in time. What we do know is that by putting people on continuous glucose monitoring, you can take that to 50%-60%.
And I expect that by when you put them on remote patient monitoring and do this more real-time feedback, plus the remote patient monitoring with a medical intervention on a monthly basis or more, you're going to see 70%-80% time in range, which is a significant improvement in the damage that occurs long-term with the high and low blood sugars.
Got it. And with these longer-term devices, and I know you're getting from 180 to 365, are you seeing demand from patients for solutions like that? It sounds like you're definitely seeing more compliance in range from them. Yeah. What we certainly know, as we said, the number one and number two request are longer-term sensors. And I don't want to have anything on the body. I don't want to look like I'm an electromechanical device, right?
So those are the two solutions.
We know that the likability is going to go up for sure. But quite frankly, we also know that the compliance is going to go up. One of the things that we referred to, the reimbursement by commercial pay at about $10 a day is actually the Medicare CMS gave Eversense an actually premium to that, which is a rare exception because they like the long-term compliance that you get with an implanted sensor. And they like the fact that it's medically placed. It's not done in the home setting. So the clinical benefit of it is pretty clear as well. That's great. Yeah. That was my next question was about the payer environment and how reimbursable you're seeing. But it sounds like not only is there willingness for these longer-term devices, there's a premium because of that compliance and damages they can prevent. Yeah.
The clinical data has now been well demonstrated that if you put people on a continuous glucose monitor, you are going to get better control. That has been used to support this, the reimbursement, both on the commercial pay. It really is still led by Medicare. We actually see today, essentially anybody that's on insulin is eligible for reimbursed CGM devices, including Eversense. Makes sense. Thank you. A little bit more on the distribution. I know you've mentioned Ascensia. You've mentioned Mercy. Could you tell us about the impact that you've had working with those in particular? Yeah. There's really three approaches that we've taken. One, we talked about the consumer being able to directly advertise to them, a lot of social media and access. You create a poll from the patient.
So the patient will go to their doctor and say, "Hey, I'd like to hear more about product X, Y, or Z." Or they'll come to our website, the Ascensia website, and get the information, and we'll talk with them from there. Avenue two is through that professional sales channel. So you'll go in, and the representatives will visit the doctor's office. They'll do detailing. They'll do training and education on the features and benefits of the products and why Eversense is a good alternative for their patients. And then the third approach is like we've taken with Mercy. That's where you do a hospital system sale, right? So you have a contract with a large organization.
Through an integrated partnership, you work to put a large number of patients on the product so they can really demonstrate integration, cohesiveness of the results, as well as the first time, we'll provide this remote patient monitoring for them so they can see their patient in reality 365 days a year if they'd like to. That's great. I know towards the end of the presentation, you shared your financials. Could you give us a sense of how those align with some of your key upcoming milestones? Sure. Rick, you want to talk about the finances and where we are? Yeah. I mean, as Tim shared, we have just shy of $100 million on the balance sheet as of the last quarterly filing. That'll certainly get us through the upcoming FDA approval and the initial commercial launch of the 365-day product.
Based on our current cash and debt repayments, we are funded into the middle of next year. We'll look to possibly draw down the remaining piece of our $50 million debt facility or look at other financing early next year.
Thanks, Rick. We are almost at time. Maybe we could just end by zooming out. Would love to hear you sum up the value proposition for investors who might be looking across diabetes investment opportunities.
Yeah. As you look at diabetes technology, the history has been pretty clear. If you help people manage their disease, they will come to you.
If you go back and take a look at any of the technologies, go all the way back to a MiniMed organization that ultimately was acquired into Medtronic, or you look at Dexcom, or you look at Pod, or you look at Tandem, or you follow where Senseonics is going to go, you see a significant uptake in utilization because people see value in it. Diabetes is unfortunately something that's going to last for 365 days every year. And you're going to need to be able to do your management as easily as you can. So technology evolution is a big part of the future. And we love where we are with a highly differentiated device in what's growing to be a $15 billion market in a couple of years.
That's great. Yeah. Very exciting. And with that, we are at time.
Thank you very much, Tim and Rick, for sharing the Senseonics story. I'd also like to thank everybody listening for spending time with us today. Great.
Thank you as well. Thank you. Take care.