All right. Hi everyone. I'm Steve Lichtman, medical devices analyst at Oppenheimer. Welcome to the Oppenheimer MedTech and Services Conference. Up next in the MedTech track, very happy to have with us Senseonics Holdings. With us today are Tim Goodnow, President and CEO, and Rick Sullivan, CFO. We're going to have a presentation. We should have some time for questions at the end. If you do have any questions, please key them in and I will get them over to management. But with that, happy to turn the mic over to Tim. Thanks, Tim.
Great. Thanks, Steven. Appreciate the invitation from the Oppenheimer team. As Steven said, we are Senseonics. We produce the Eversense continuous glucose monitoring system. We are a technology company, obviously in the diabetes technology space. Today we'll be speaking about our opportunities in CGM and, of course, making forward-looking statements. The area of diabetes management obviously is one of very important societal interests. There are 500 million people around the world that are in diabetes or pre-diabetes. Obviously the evolution over the last decade or so, transition to CGM has been one of the important areas and has really helped change the management of both type 1 and type 2 diabetes because of the new technologies that exist.
Our opportunity and our responsibility as Senseonics is to do just that, try to be able to help people with diabetes live safer, live longer using the new technology capabilities. We do that through the introduction and commercialization of a long-term implant, CGM. We have a rich history of innovation and development. We started about 5 or 6 years ago with the first commercialization of a 90-day product. There are 4 CGMs that have FDA approval for CGM. We are one of them. We are the one that is different, if you will. The other 3 are transcutaneous sensors. So they actually use an enzyme. They generate current, which correlates to the amount of glucose that's there. But because that's an enzymatic system, it actually needs to be replaced, depending on the manufacturer, somewhere between 7-14 days. We've taken a different approach.
We're not enzyme-based, but we do it with a long-term implant. What you offer the patients with that long-term implant is an opportunity to put the sensor in. You get the continuous results. You don't have to do any management of that sensor, any replacement of it. What you do, it is required, of course, that you go to the doctor's office to have the sensor put in. We've been working on the frequency of that. We first commercialized in 2018 and 2019 our 90-day product post the impact to the FDA and their review cycles. We actually launched the 180-day product in 2021. Now we are on the cusp of actually submitting for and we will receive approval, anticipated approval, in the fourth quarter of this year for our 365-day product.
So we're excited about the evolution of our technology and the opportunity that we're bringing to people with diabetes. So just briefly on the market, it's unfortunately a very big market. You've seen a transition and significant growth. We're still growing at a little bit over 20% CAGR. We will do just over $10 billion this year globally, the largest market by far given the maturity and the reimbursement opportunities in the United States. But we are seeing that grow now at $2 billion a year. And we're excited to participate in that financial aspect of it, even though it is a very significant disease.
When you speak to people about continuous glucose monitoring, whether those are people that are on the technology today, CGM, or whether they are the people, excuse me, that are not on it yet and have chosen not to go on it, what are their two biggest requests? Well, obviously the sensors need to perform, which most of them do at this point. But they also want it to be long-lasting, right? The fundamental goal of diabetes technology, if you take a look at any of the folks that have been able to be successful, is that you have the reality of a disease that, unfortunately, once you're diagnosed with it, whether it's type 1 or type 2, there's no cure for it. You are going to need to manage it for the rest of your life. And monitoring the glucose level is a big part of that.
So you want to be able to make it as simple as possible. Same thing goes with insulin pumps. If you've seen successes in that space, it's all been as the technology companies have made them easier to use, you've got more and more adoption. And we obviously want to be a big driver in the further evolution of CGM. And they're looking for two things. They want to make it last longer so that it, again, impacts their daily life, the rest of their lives, as little as they can. And they'd also like to not have anything on the skin, right? They'd like to be able to eliminate, with all technologies today, there's an electromechanical patch. In the transcutaneous sensors, there's a big move to make it as small as you can. We are going to do a leapfrog in that technology.
We're actually going to eliminate any of the on-body. You can only do that by actually doing a full implant. Just by definition, with a transcutaneous sensor, you're going to have some component on the surface. Our job right now, and we're actively working on taking the 365-day chemistry that we will be submitting the clinical results for shortly, and actually incorporating the Bluetooth technology inside the implanted sensor so it communicates directly with the phone. In that case, people using Eversense would have nothing on the skin. There'd be no adhesive issues. There'd be no monitoring of that replacement of that on-body transmitter. So that's a big part of our technology: duration and elimination of the on-body component. So what is Eversense today? We currently commercialize a 180-day sensor. It's shown in the center of the screen there. It's quite small.
It's about 16 millimeters long by 3 millimeters wide. It's a tiny acrylic rod with chemistry, glucose recognition chemistry, on the surface of it. It's inserted under the skin by a clinician in the back of the arm. There is a removable and replaceable transmitter that powers the sensor. It does it through near-field energy. So that's the same as your Apple Pay or Google Pay. So in the proximity, it provides the LED sensor with the flash capability, which generates the glucose result every 5 minutes. And then it calculates that inside the transmitter and then communicates it via Bluetooth to the phone. Because all of that calculation and determination is done, we use what we call a smart transmitter because it is a standalone medical device. You don't actually have to have the phone. And it will communicate with you through on-body vibratory alerts.
There's a very specific vibration alarm for high glucose. There's another one for low glucose. If you want to know the exact level, then you do use your phone and it's there. At any point, you don't have to be in proximity to your phone all the time. When you do come back to it, if you're out in the backyard or you run downstairs to do the laundry, as soon as you come back in proximity to your phone, it'll catch up, transfer all the data. And then, of course, once it's on the phone, it's all pushed to the cloud. So because it is a transmitter that doesn't go through the skin, we're actually able to replace that every day. We encourage folks to take it off, take your showers, clean the area. We use a silicone-based adhesive, which is high vapor transmission, high oxygen transmission.
The replacement scheme is very nearly eliminating any of the adhesive reactions, skin reactions, that you see with some of the other more harder acrylic-based adhesives that exist. And because it's able to come off, we do have MRI compatibility that exists. The sensor does not have to come out. So highly accurate. Obviously, that's a game-changing requirement to participate and for the regulatory approval for the iCGM designation that's coming. Our experience today in the center, we get a lot of questions about what is your typical user. We actually don't have a typical user. As you can see, the distribution amongst all the deciles is pretty equal. The younger population tends to be very interested in the product because the transmitter has the ability to come on and off, right? So if you're active, if you're sweating and exercising, you swim a lot, you really appreciate that capability.
On the other end of the age spectrum, the people, especially the Medicare population, which is our fastest-growing segment, is they have a high interest in the doctor being able to do the insertion. It stays in for a long time. And they don't have to deal with the dexterity or the reinitialization that goes on with the one or two-week sensors. We are seeing about 30% of our patients are actually coming from new to CGM. So these are folks that have known about it, but for one reason or another, they've opted not to go into the CGM world. The implantable gives them attributes they're looking for. And about 70% of them are actually switching. So they're coming from one of the three existing brands, predominantly Dexcom and Libre. There's lower penetration of the Medtronic product. And they also have the exclusive integration with their pump.
The type of patients, as I said, we are seeing, although we started with over 90% Type 1s in our early launch today, we're seeing about two-thirds of our patients that are actually coming from Type 2 diabetes. The balance is still Type 1 diabetes. What they're looking for, again, is sensor life, the convenience of that on-and-off transmitter, and just have the flexibility to wear it when they'd like to wear it, so. Coverage is actually very good. We have essentially ubiquitous coverage now. Much like the other CGMs, we are reimbursed at about $10 per day for the implantable sensor and transmitter itself. So it's about $1,800 reimbursement for a 180-day sensor. We anticipate that doubling to $3,600 with the one-year sensor in commercial pay.
In Medicare, it's a little bit different because they see the advantage of the compliance and the long-term utilization, which is an issue in their population. There's actually a premium that Medicare has provided for Eversense of about $16-$18 a day, depending on the zip code that you're in. So in addition to that, because we have CPT codes for the professionals to do the procedures, there's also payment under those CPT codes to actually place and reinsert this sensor. That runs in commercial pay somewhere between $250-$400. In Medicare, it's typically between $400-$700, depending on your geography. Commercialization is accomplished with a partner, Ascensia, which is Ascensia Diabetes Care, which is a traditional strip-and-meter business, as our commercial partnership. They are a division of PHC, Japanese healthcare corporation. Many are familiar. They do upwards of nearly $1 billion of strip-and-meter testing.
This is their foray into CGM. So Senseonics has responsibility for design, development, and next generation. We fund all of those activities. Ascensia funds the commercial activities. So that's the distribution. That's the feet on the street. That's all of the reimbursement development. And for that, we have a revenue share that we split between the two organizations, which is tiered based on levels and based on duration of the development. Our commercial strategy is to work with ADC, so the Ascensia Diabetes Care Group. They have a dedicated CGM business unit, which was frankly just formed. It used to be a partnership with a BGM group. It is now standalone and exclusively focused on Eversense alone. And we just announced in partnership with ADC that Brian Hansen, who was the former CCO of Tandem Diabetes Care, has taken responsibility for that commercial execution.
We're excited to have him on board. The insertions are done by a network today of about 800 inserters around the U.S. that do the insertion and removal process. We have about 3,000 folks that actually prescribe the product. Outside the United States, there's a little bit over 1,000 people that are doing it in predominantly Italy, Germany, and a few other select markets. In addition, we have a partnership with the Nurse Practitioner Group. This is a network of nurse practitioners, as this meets our label, that has the ability to do the insertion and removals. They are regional. They will actually come to your home to do it as well. This is an exciting growth opportunity for us as well. We're looking for a pretty significant expansion in the via the nurse practitioners to expand our capability to bring it to folks.
Ascensia has initiated in the third quarter a more comprehensive advertisement marketing campaign. It includes broadcast television in select markets, quite a bit in connected TV, as well as the typical social media. So you can actually see the advertisements. The opportunity there, of course, is to educate and train on the implanted product, both at the consumer level, but also at the professional level as well. So it's a multi-tiered strategy and one that folks are quite familiar with. So that's our bring-to-market strategy. It's done in partnership. As I said, Ascensia has the responsibility and investment. And Senseonics does the manufacture, the design and development, and the pipeline development. So in that pipeline, the vision that we're focused on is to have one single sensor shown here that lasts an entire year. That would be placed by the medical professional under those CPT codes that we spoke of.
It lasts a full year. We do no daily calibration. We've eliminated the need for that. As I said, we're headed to a direction of a product that has nothing on the skin with no transmitter. So that's our vision. We're implementing that right now. As I said, in the top line, we actually are currently commercializing the 180-day product. And I anticipate that in the coming weeks, we'll actually receive. We've submitted and have answered all final questions for the FDA for our iCGM designation. So I expect, as I said, in the next few weeks, it will have approval for the 180-day product. Right behind that, we'll actually be submitting the 365-day product. We've completed all the data collection for that. It'll go to the agency. And we do anticipate that within two quarters, we'll have approval for the 365-day product.
With the Ascensia commercialization partnership, we will transition the market from the current 180- to 365-day product. Beyond that is the product concept that we're actively working on now. In fact, we'll do our first in-human testing of the Gemini product this summer. The Freedom is the next step there. On a 365-day product that we'll be submitting, what we have actually published, you saw it last year's ADA. We'll have the seminal data here on 365 at this year's ADA. We've shown data from our pilot study through a full 365-day. We do have 1 fingerstick per week, which is consistent with the frequency that some of the CGMs actually replaced that. We're comfortable. We'll be highly competitive with the highly reduced calibration scheme. We've shown very strong MARD, where we expect it to be at about 9%.
We're demonstrating survival north of 90%. This is the data that's equivalent to what'll be submitted, a much larger data set that will be submitted to the agency. We're excited about its approval. It will form the basis for the chemistry and technology that we use on our coming next-generation products. First of those, as I said, as Gemini, we describe it as Gemini because it really has two ways that it can be used. First and foremost, it can be a traditional CGM, most typically used for those people that are on a pump where they're treating Type 1 Diabetes. It will report in real time the CGM via the on-body transmitter. It'll be self-powered. What's shown on the left is we are working with a partner that has a long history in implanted battery technology.
So it will power the sensor for a full year, collect it, and generate the full response of CGM results. The second way, when that's generated, if you don't want to wear the transmitter, which would typically be someone with type 2 diabetes who isn't looking for those nighttime alarms and alerts, but is more looking for a facile, fit-in-their-life way, is it will also be scannable. So you'll be able to swipe it using the near-field technology that exists with your phone, as shown on the right side. And it'll collect up to 8 hours' worth of your last CGM glucose profile. So you don't need to wear the transmitter in that application. You can swipe it when you get up in the morning. And you can see what your entire glucose profile was overnight.
We really expect that you can use that for both type 1 diabetes, intensively treated type 2 diabetes, or the large new indication for people with basal-only indication with type 2 diabetes as well with the swipe. Then ultimately, the technology right behind that, the last step for us is to actually include the Bluetooth technology. That is coming. We're actively working on it. Again, we would do this on the 1-year sensor technology. So lasts a full year, battery lasts a full year, and will now have the Bluetooth communication. That will communicate directly with the phone, sending all the alarms and the alerts. That technology could be used, of course, for people with type 1 diabetes because of the real-time alerts, but also, of course, all cases of type 2 diabetes.
So we really think that's the biggest point of differentiation for us and opportunity for us to really maximize the implanted technology, to have nothing on the skin. We know that between that duration and the fact that it'll be completely invisible to anybody with diabetes, you won't be able to tell that people are using the technology or have it. We know that we're going to get a lot of interest in that product as well. So we're certainly excited about it. This is a very important year for us with the 365 coming. We've been building this for a number of years. We have the reimbursement in place. We have the commercial infrastructure in place. We have the insertion network in place and growing. So we're excited about where we were. And with that, I want to thank everybody for the opportunity, the interruption.
Steven would be happy to answer any questions that may have come in.
Great. Thanks. Yes. We do have a question that came in. We'll get to that first, I guess. The question is, what applications like ketone monitoring, I guess, or other analytes can we expect to see in the pipeline and what time frame?
Yeah. So we haven't given dates on the time frame. What this new chemistry, it actually is a redundant sensing capability. So what we're using it today is we have two glucose sensors that are in each. What we recognize, of course, for those, predominantly in Type 1 Diabetes, we can use one of those to measure ketones. So that design work is actually going on right now. It'll come out as a part of that Gemini system. That flexibility still be there. So it's probably at least two years down the road. But that would be the opportunity to expand the capability and very, quite frankly, easy to do with this redundant measuring capability that exists in the Gemini sensor.
What is the timing of Gemini? And just to be clear, is the mobile device for swiping, is that directly to the phone, or will that be a dedicated handheld?
No. It's a commercial phone, whether that be an Android or iOS. So we're using the same near-field technology. So Gemini will do first-in-human testing during the summer. We will get the authorization to do the informative testing on it. And then we anticipate filing for the IDE so that we can do the pivotal trial by the end of this year. So that would likely be commercialized in the 2025-2026 time period.
Wondering how you think about guidance. I believe you provided sort of first-half guidance because there's a lot of different moving parts. But I guess, how are you sort of managing your outlook during the period that you get closer to 365 days? I would think perhaps there'll be some pausing, patients waiting for that device. I mean, how are you kind of thinking through getting that visibility during that period heading into approval?
Yeah. So that's the active approach right now. As you said, there's a couple of dynamics going on. One, as you mentioned, is this transition from the 180 to the 365-day product. We know that there will be some transition. And we're working actively with Ascensia to manage their inventory so that when we do cut over, we do it with the smoothest transition that we can. The other reality is we did announce in partnership with ADC the addition of Brian Hansen, as we spoke of. So he's been on board for about 60 days now. And he'll be laying out all of those commercial activities with a big plan for the investment and the focus on the 365-day product as well.
That's coming together for us here in the next month or two, as well as there's some other initiatives in the IDN area or ACO opportunity that we're actively working on that we'll be flushing out in the next few months and give guidance for the rest of the year. So far, we've guided the first two quarters to just about $10 million.
Tim, you alluded to this. What are sort of some of the biggest learnings that you and Ascensia have had in terms of the commercialization to date and some of the changes that you're sort of partnering with them to implement?
Sure. So obviously, one of the things that we've been very excited about is we have seen significant interest as they ramp up the investment in the marketing and advertising. We've seen a 300% increase in interest in the product and leads that are generated. So one of the big things that they're learning and putting together right now, this is a lot of what Brian is working on, is making sure they've got the investment in place, the infrastructure in place to take these leads and turn them into actually implanted sensors. So that's been a big learning for them as well. We've participated pretty significantly in the continued advancement of our network. We're using predominantly nurse practitioners and PAs that work on a contracted or a reimbursed base, since this is a reimbursed procedure, in their local areas to actually do the insertions and removals.
So we're expanding that out. We've got about 35 regions that we work with today. And we're looking to significantly grow that here in the next couple of years as we go forward. So that's been a big part as well. And then obviously, the reimbursement has been important as well. We've transitioned with Medicare, first approval for a 90-day product. We work with them and now have the 180-day product approved. And we're going to just start again on the 365-day product. So obviously, the reimbursement and transition in Medicare, as well as commercial payers, has been a big part of what we've been working on as well.
Based on the previous experience with 90 and 180 on reimbursement, how quickly do you think 365 could get initiated?
I think it'll go actually quite quick. We've seen it go pretty quick in commercial as they are per diem payment. They're used to it. It's a little bit more quantized with Medicare in that they have the annual process that they use. Since this is a medical benefit, it's done under the physician fee schedule. And as you know, that's published in the December time period. So we'll be working with them to make sure that we are right on track to make that happen as well.
And then can you talk about the progress and the hurdles of sort of removing the transmitter altogether, sort of the Freedom program? What are the key milestones that investors should be looking for from you guys in the coming quarters and years as you look to bring everything sort of in body?
Yeah. So there's really two big technological steps that need to happen because there's two things that are done in the transmitter. One is the powering. So a fully compliant, fully capable, year-long battery is the first step. And we've made great progress with that. And as I said, the big milestone for us is we will do the first human testing on that implant-grade battery here in this summer. The next big technological step, which really drives the Freedom, is the incorporation of the Bluetooth. So Bluetooth requires a separate antenna, a chipset, and its powering. And that's what we're actively working on in the research phase right now and why it's a little bit further out because you do need to have that Bluetooth capability that works to the phone, and it works every time that they need it.
So that's what we're focusing on, the technology development so that when you roll over on your arm at night, you're still able to get a good, strong signal to the smartphone. That's exactly what we're dealing with and doing that with all the power requirements with that implantable battery. So those are the big two steps. We're partnering with the right people for both of those, the development, incorporating it, and keeping it in our tiny implant-sized sensor.
One last quick one. This came in. Can you talk to what your install base is, how many customers are using in the U.S. and Europe?
Yeah. So we announced that last year, we completed, we were at just about 4,500 patients. We anticipate, as we said, about two-thirds of those are Type 2, one-third are Type 1. But this is a pretty significant ramp year for us with the 365-day product coming forward. So we're expecting pretty material growth this year.
Great. Well, we'll leave it at that. Tim, thanks so much for being with us, Rick, as well. Thanks, everyone, for joining us today. I hope you have a great rest of the day and rest of the week. Thank you.
Great. Thanks, Steve. Appreciate the opportunity for having me on the team.