Good morning, and welcome to the Jefferies Healthcare Conference. It's my pleasure to now introduce Shantanu Gaur, Founder and CEO of Allurion.
Thank you very much, everyone. I'm Shantanu Gaur, founder and CEO of Allurion. It's a real pleasure to be here with you this morning, and we founded Allurion back in 2009, really with one goal in mind, that's to end obesity around the world. And to that end, we're off to a very interesting and fast start. We're in the obesity space, and this is clearly one of the biggest problems in healthcare, one of the biggest unmet needs in the world. Analysts are calling for this to be a $50 billion-$100 billion revenue opportunity by 2023. And what we've developed at Allurion is really a proven technology that delivers, on average, 30 lbs of weight loss in just four months.
But crucially, 95% of that weight loss can be maintained one year after our device leaves the patient's body. So not just a focus on weight loss, but a focus on weight maintenance. We're operating at scale already. We've already treated over 130,000 patients around the world, and we have a clear path to over 80% gross margins and profitability. I think one of the most exciting parts of our development over the past couple of years has been the expansion of our AI platform, which is coupled with our balloon, and recently we launched Coach Iris, which is our 24/7 weight loss coach, powered by GPT, and also powered by and informed by millions of data points from patients around the world. We have several upcoming catalysts, among them our eventual U.S. launch.
We're moving through the U.S. regulatory process right now, but also expansion, further expansion of our AI platform, with more features, in generative AI, that we believe can make it an even more customized and personalized experience for patients. We've had a strong track record of growth. Over the past six years, we've grown top-line revenues 100% year-over-year. I mentioned that we've already treated 130,000 patients, and just to give you a sense of the engagement that we get from those patients, just last year alone, we had over 2.5 million app sessions, that are constantly collecting data points, through the app and through our wearables that end up feeding into and informing our AI and machine learning algorithms. Our balloon, which I'll get into in a few minutes, is truly revolutionary.
It's covered by over 40 patents all over the globe and has really taken a 40-year-old gastric balloon technology and brought it into the 21st century. You're probably very familiar with the obesity epidemic and, you know, the issues related to weight loss that people encounter everywhere around the world. When we founded Allurion, now close to 15 years ago, there was a clear track record of failure in the weight loss space.
Many innovations, both in med tech and in biotech, had failed to deliver long-lasting results, and we started Allurion to fix those issues and fix those problems. And we boil it down to really five key areas. The first is a poor experience. Oftentimes, people who get a medical device or a weight loss drug often don't have the proper monitoring and don't have any emphasis on behavior change. We've solved that at Allurion by creating a program that wraps around the patient to teach healthy lifestyle and healthy behaviors. There's also the issue with high risks. Anything that requires surgery or endoscopy or anesthesia inherently is gonna be riskier in a population that is at a high BMI, and it's also gonna be more expensive.
When you think about the cost of bariatric surgery out of pocket, it's $15,000. These new GLP-1 drugs are over $1,000 a month. It's just out of reach for most middle-class consumers. We solved that by taking the procedures out of the equation and making it much more affordable and safe for the patient. And then finally, providers have a real issue with historical weight loss devices because they do have so many procedures attached to them, and it makes it very difficult to deliver those procedures at scale.
Moreover, it makes it more difficult to find patients who are actually suitable candidates for those types of procedures. We've solved all of these issues at Allurion, and that, I think, explains, in part, our rapid growth over the past several years. The time is now in the obesity space. I'm sure all of you have been following the rise and prominence of these GLP-1 drugs, something that we've actually been following since Saxenda got approved back in 2015 for weight loss. It's really the first generation of GLP-1s that was approved. Analysts are calling for massive growth in revenue in the weight loss market.
GLP-1s have made obesity mainstream on social media, but also the mainstream media, and it's something that we've watched evolve over the past eight years and accelerate with the approvals of Wegovy and Mounjaro, and I really like the positioning that we have at Allurion vis-a-vis these drugs. First, there's an entire segment of the population that simply doesn't want drugs and doesn't want to experiment with weight loss medications, especially with long-term use.
That's a population that Allurion could serve as a first-line weight loss therapy. But there's also this issue of churning off of these drugs, where Allurion could potentially be a second-line or even combination therapy to drive even better weight loss results. And these GLP-1s have faced some challenges, even amidst all of the fanfare around them, that Allurion can capitalize upon. The first is really related to the experience of taking these GLP-1s.
Right now, they are injectable drugs. The churn rate is quite high. You know, when you look at a study done by Prime Therapeutics, it's a PBM in the U.S., there's a 68% churn rate within one year of starting these GLP-1 drugs, and that's with real-world use. Part of that is related to some concerns around the adverse events, especially as patients escalate their GLP-1 dose. Part of it is related to cost. These drugs are over $1,000 a month, but also part of it is related to the weight regain. Once you stop taking these drugs, the weight does come back on.
So if you think about the millions of patients who are now entering the doctor's office interested in weight loss because of these GLP-1 drugs, many of them will churn off of them, and those patients could be fantastic opportunities for Allurion to capitalize upon and bring into the fold. So what have we actually created? What is our solution? Our program has three pillars: our device, our AI platform, and our behavior change program. Our device is something that can be delivered in a 15-minute office visit. It's a balloon that comes in a capsule attached to a very thin tube. You swallow the capsule, it goes down into the stomach, the balloon is filled through the tube, and then the tube is removed. 15 minutes start to finish.
We like to say you can do it on a lunch break. There's no anesthesia or sedation involved, no endoscopy or surgery involved, and that, and that balloon spends four months inside the stomach. Takes up space, prevents you from overeating, and also then opens up on its own and passes out of the body. So there is literally no return visit required to remove the balloon. It gets rid of itself and passes naturally after four months.
So a much more frictionless and convenient experience for the patient than, say, bariatric surgery or an endoscopic weight loss device, or even injecting yourself once a week with a GLP-1 drug. The balloon is just part of the story, though. The day you get your balloon, you also get our Bluetooth scale, you get our smartwatch. If you have your own devices or if you have an Apple Watch or a Samsung or a Garmin, all of that integrates with our platform as well, and you download our mobile app.
And on our mobile app, you can actually track and see all of your data as a patient, but all of that data coming from the watch and scale, and Apple Health can also be viewed by your provider. So we've created a software platform for our providers to monitor and track their patients as they go through their weight loss journey. This provides a much closer connection between provider and patient, and all of that data also feeds in to our AI platform, and I'll go into in a few minutes some of the ways we actually use AI, using this data to actually drive better patient outcomes.
The third pillar is our behavior change program. We have an entire team inside Allurion devoted to behavior change. We've created over 150 modules of content related to healthy eating, exercise, good sleep hygiene, mental health, stress management, and all of that content is digitized and delivered through our mobile app. So as a patient goes through their weight loss journey, they have a balloon inside of them helping them eat less, but they are also learning how to change their behavior, and in real time, they're being monitored by their care team to make sure they stay on track.
Just double-clicking a little bit on the balloon, it's made from an incredibly thin polyurethane film that is much thinner than the silicone used in legacy devices, and the material was specifically chosen to be very smooth on the gastrointestinal lining because the balloon is spending four months inside the stomach, and it's durable enough, however, to withstand a pretty toxic environment inside the stomach for four months. The film is so thin that the balloon can be wrapped and folded into a capsule. That's actually how we're able to generate a device that is swallowable in a very small capsule in a 15-minute office visit. The balloon has two valves on it. The first is the fill valve.
That's where the tube is connected to the balloon, and once you remove the tube, the balloon, through the fill valve, actually self-seals and creates a watertight seal to prevent leakage as the balloon spends time inside the stomach. The second valve, the release valve, is what allows the balloon to open. The release valve is constructed from a degradable polymer, and that polymer, over four months, degrades. Once it's fully degraded, the valve opens up on its own autonomously, the balloon empties out and passes out of the body. I mentioned that we leverage AI at Allurion to drive better patient outcomes. Here's one example. We released last year something called the Success Predictor Algorithm.
This was a machine learning algorithm that we trained on over 7,000 patients' worth of data. What this algorithm can do, by looking at 12 different variables that data is collected on from the wearables that we provide, within 20 days of someone getting our balloon, this algorithm can start to make a call as to whether or not the patient will cross 10% total body weight loss at four months. So this gives the provider, in the software suite for the provider, which you see on the screen here, this gives the provider a view with a green check mark or a red flag, super simple, as to how that patient is tracking.
So if you have a panel of 100 patients who have our balloon, there may be five or six, for example, that have a red flag next to them. Those are patients that might need extra care and intervention to help them get to at least 10% total body weight loss. So this allows the provider to streamline their workflow, focus on the patients who need the most care and attention, and maybe focus a little less on the patients who are just on a glide path to success.
And this is the type of algorithm that potentially could be very useful for any sort of weight loss practice, even if they're not using our balloon. For instance, for patients who are taking a GLP-1 drug, or even patients who are going through bariatric surgery. We're very excited about the launch of Coach Iris. We launched Coach Iris in October of this year. It's our first foray into generative AI. We have spent really the last year training Coach Iris on our behavior change program.
Coach Iris is powered by GPT, the same technology behind ChatGPT, but unlike ChatGPT, which is taking information and data from the entire internet, Coach Iris is really trained on our behavior change program to provide evidence-based guidance to patients 24 hours a day, 7 days a week. So on our mobile app, you can ask Coach Iris literally anything about your weight loss journey. And what we have found already with patients using Coach Iris is that they appreciate the high levels of engagement and empathy that Coach Iris provides. The coach is always on, always empathetic, always has time for the patient.
And providers really appreciate Coach Iris now being one layer below them to answer questions that patients may have, that they really don't have much time to, to field and answer. So Coach Iris, we believe, is gonna be instrumental to both the provider to handle increasing patient volumes, but also for the patient as a guide and as a coach that is always there, always on, and always focused on making sure their weight loss journey and their weight maintenance journey is a success.
Our vision for Coach Iris and generative AI in general is to create a fully personalized and customized experience for our patients. In the future, I really believe that from a consumer or B2C standpoint, we have the ability now, through the power of generative AI, to build an infinite army of coaches that have the right feel and the right touch and the right level of empathy for different types of patients. Our goal on the B2B side for our providers is to give them an arsenal of coaches who look and feel like them and their practice and their staff, and really are those practices' employees of the month every single month.
Now, our goal for Coach Iris is to really become instrumental to each and every weight loss practice's day-to-day operations as that first line of defense, and first line of contact for patients, no matter where they are in the world. So now that you know a little bit about our program, you know, what are the results? The results are very clear. We've now treated over 130,000 patients with our program, and, you know, what we see with just one balloon cycle is 30 lbs of weight loss on average in just four months. If you come back for a second balloon, which some of our patients do, you can get 50 lbs of weight loss on average in 12 months.
But crucially, 95% of that weight loss is maintained after 12 months, 12 months after the balloon has left the body. This is where our focus on behavior change, our focus on lifestyle modification really shines through. For most weight loss therapies, as soon as the therapy is done, the weight begins to come back on immediately. It's important, I think, to really note that Allurion is not just a weight loss business or a weight loss program. It can have a tremendous impact on any obesity-related comorbidity. For instance, our patients who are diabetics, on average, they see a drop in their A1C of one and a half points. That's good enough to put most diabetics into remission.
Pre-diabetics see over a point reduction in their A1C. That's good enough to put their prediabetes into remission. As you can imagine, with this magnitude of weight loss, you see improvement across the board in most obesity-related comorbidities. And this is really just the start of our journey at Allurion. We are generating a compelling clinical data set across a number of different axes. We just presented some data earlier this year at SAGES, looking at one-year weight loss results that potentially could be even better than what we had previously published. This was a study in 232 patients, where we continued following these patients after the balloon had left the body, and we dialed up the intensity of the lifestyle modification program.
In these patients, instead of just maintaining the weight loss, we actually saw additional weight loss after the balloon had left the body. These patients lost 17% of their total body weight at one year. We're also very interested in combination therapies. I think, you know, in the future, for obesity care to really scale, devices, drugs, and surgery are going to be combined, and used in different phases of the patient's weight loss journey. This was a study done in patients, in 181 patients, who were treated with the Allurion Program for four months and then started on Saxenda, which is an older generation GLP-1. These patients were treated with Saxenda for four months, so four months of our balloon, followed by four months of Saxenda.
They lost 19% of their total body weight at eight months. Just showing the potential here for the magnitude of weight loss that you can achieve when you combine a device like ours with this, with a GLP-1 drug. And mind you, Saxenda is an earlier generation, less effective GLP-1. I believe these results could be even better, with Wegovy or Mounjaro. So looking to the future now, we have several growth catalysts ahead of us.
Over the next several years, we really have three main areas of focus. One is to expand revenues in our existing markets. The Allurion Balloon's approved in over 80 countries today. To launch in new markets, most specifically the United States market, which I'll shed a little bit more light on. And third, and I think, you know, what excites me most is expanding our platform, specifically our AI platform, to engage patients over the course of a lifetime.
Right now, we're very much focused on weight loss and weight maintenance over the course of years. I'm very interested in building Allurion to serve patients over the course of decades. With regards to the U.S., our IDE for the AUDACITY trial was approved back in 2022, in November. And we began enrolling patients in early 2022 or late 2022, and we completed enrollment in October of 2023 in the AUDACITY trial. This is a randomized controlled study, open label, two groups, either the treatment group or the control group, focused primarily on the balloon, so not including our behavior change program or our AI platform. This is just looking at the balloon.
Patients in the treatment group are eligible for up to 2 balloon cycles over the course of a 48-week period, and the control group just receives moderate intensity lifestyle therapy, which amounts to roughly a once-a-month visit for about a half an hour to a dietitian. So a very low-touch lifestyle modification program, hence the focus really on the balloon safety and efficacy profile. The co-primary endpoints are listed here. 50% of the treatment group patients need to cross 5% of total body weight loss at 48 weeks, and we need to show a 3% superiority margin over the control group at 48 weeks.
This is going to be one of the first device studies in weight loss that's going to show results at one year, and I believe that could be a very interesting opening for us to begin conversations around reimbursement in the U.S. once data from the AUDACITY trial is available. Now, we already have quite a bit of experience with sequential use of our balloon outside the United States. This is one of our studies where we showed that with two balloon cycles, similar to what we are doing in AUDACITY, patients lost over 20% of their total body weight at one year. And in this case, in this study, 100% of patients lost more than 5% of total body weight.
Nearly 100% of patients lost more than 10% of their total body weight, which is roughly double the weight loss that we need to achieve in the AUDACITY trial. So we already have a fair bit of data on two balloon cycles that increases our confidence regarding AUDACITY, and we'll be providing further updates regarding AUDACITY in our PMA submission in future earnings calls and future presentations. So I'll conclude just by talking a little bit about where I see obesity and weight management going in the future. Right now, we're very focused on the middle part of this slide, where we've expanded, actually, the use of our software and AI platform to support patients who are going through not just our balloon, but getting a medication or getting bariatric surgery.
We're focused right now on turbocharging those results, making that a best-in-class experience for patients. But when I look at all the data that we are able to collect and all of the algorithms that we could train, I really feel like the future in the weight loss space is to provide patients more guidance after their first therapy is done. You know, their balloon, their bariatric surgery, or their GLP-1 drug is just the start of their weight loss journey, not the end. And so in the future, I'd like to leverage our AI platform to provide those recommendations to patients over the course of years and decades, to give them a treatment plan that can last a lifetime.
Because at the end of the day, obesity is a chronic disease. It's not something that can be cured, but it can be managed over the course of a lifetime. With enough data, we could actually circle back to the front part of this flowchart, where at the get-go, from the start, we could potentially recommend the right treatment for the right patient at the right time.
And so with the platform that we have developed, I really believe that we can start building this future of weight loss and obesity management, starting with the balloon and our existing AI platform, but certainly very quickly expanding beyond that. So I'll stop there. I'll leave this slide up as just a summary of the presentation, but happy to take any questions from any of you. Thank you. Any questions? Crystal clear. If any of you need balloons before lunch, let me know. More than happy to provide. Thank you, guys. Appreciate it.