TD Cowen Healthcare Conference. I'm Josh Jennings from the TD Cowen Medical Devices team, and we are excited to have Allurion management here. It's a big year, 2025, for the company, moving towards FDA approval for the Allurion Weight Loss Balloon Gastric Balloon, and we are. Multiple other revenue channels that have been opened up. I'm going to hand it over to Dr. Shantanu Gaur to run us through the presentation. It's great to have you here, and thanks for participating.
Good morning, everyone. I'm Shantanu Gaur, founder and CEO of Allurion. Thank you for coming to the presentation this morning. As Josh mentioned, we are in the obesity space, and it's probably no surprise to many of you that obesity is a significant problem with major ramifications all over the globe. Analysts point to an over $50 billion revenue opportunity by 2030. That's only growing by the day, especially with the rise of new therapeutics like GLP-1 drugs. We tend to look at obesity from a slightly different lens. There's 2 billion people around the world who are overweight, 1 billion of whom have obesity. And just as a benchmark, there's only approximately 600,000 bariatric surgeries done every single year globally, which represents only about 1% of the population around the world that qualifies for bariatric surgery.
There's a massive opportunity here, not just in the bigger opportunity related to being overweight and obese, but also people with higher BMIs who are saying no to bariatric surgery. There have been several different attempts at cracking the code in obesity, but we believe they all suffer from the same four shortcomings that you see here on the slide. The first is weight regain, and this is particularly acute with GLP-1 drugs. The moment you stop taking the medications, if your lifestyle and behavior have not changed, the weight will just come right back on. Anything that's not paired with a holistic behavior modification program is doomed to have weight regain as part of the equation. The second thing that we've all observed is muscle mass issues, especially with GLP-1 use.
40% of the weight that you lose on a GLP-1 can actually come from muscle mass, which leads to a lower metabolic health profile when all is said and done. Third is side effects and tolerability. This is true of bariatric surgery and also GLP-1s. Anything that requires anesthesia or endoscopy in a patient with obesity is going to be higher risk for cardiovascular complications. When you look at GLP-1 drugs, 50%-75% of those patients will actually stop taking their GLP-1 within the first year. 30% will stop within the first month. A lot of that has to do with the side effects and intolerance that come with those medications. The fourth is untenable economics. When you look at bariatric surgery, out of pocket, on average, it's around $14,000, can be as high as over $30,000 with limited insurance coverage.
With GLP-1 drugs, these are lifelong medications. The moment they are stopped and the weight comes back on, the obesity will also come back. To be on these drugs for a lifetime is just inordinately expensive. We've taken a very different look at Allurion, and we believe that our weight loss program really solves all of these shortcomings. First and foremost, our weight loss program is complementary to GLP-1s in two respects. The first is our balloon program can actually be combined with GLP-1 drugs to boost efficacy and potentially actually lower the dose that's required of the GLP-1 medication, which will improve the cost, which will improve the side effects and tolerability, and potentially improve the long-term adherence. We've recently expanded our clinical pipeline to start studying the combination effects between the Allurion Balloon and GLP-1 drugs. The Allurion program is also a potential second-line option.
We've seen already that 33% of our patients are trying the Allurion program after they have already tried a GLP-1 medication. I suspect that in the near future, that number is actually going to go up as more and more people try out GLP-1s, realize they're not the right long-term fit, and then go to a different option. Our weight loss program is built around the Allurion Balloon, which is procedureless. It comes in a capsule. It's attached to a very thin catheter. It's deployed in a 15-minute office visit. No sedation, no anesthesia. The balloon is swallowed, goes into the stomach, filled through the tube, and filled to about half a liter in volume. The balloon then stays inside the stomach for four months, helps you lose weight by inducing early satiety.
After four months, there's a patented valve, which is now covered by over 60 patents, that opens on its own. The balloon empties out and passes out of the body; incredibly simple approach that can drive, as you'll see, best-in-class clinical results. It's also a very safe device. We have a 10 times lower serious adverse event rate than any previous endoscopic liquid-filled intragastric balloon. That's partly because our approach is procedureless. There's no endoscopy or anesthesia involved. There's also lower intolerance. Our intolerance rate after patients get the balloon is a fraction of previous endoscopic balloons that have been on the market. Most importantly, our program truly works. We've already treated over 150,000 patients with this balloon.
What we've seen is an average weight loss of 15% of total body weight after just four months, with 95% of that weight being maintained at one year. That is because this is not just a balloon. As you'll see, we combine our balloon with an AI platform that drives behavior change and lifestyle modification in parallel with having this balloon inside the stomach. Our balloon can also be repeated. When patients do repeat the balloon and get a second cycle, the weight loss moves up to over 20% total body weight, 20% total body weight loss after a full year of therapy. Again, that is in combination with our digital platform and behavior change program. What we're very excited about is we've seen some initial signals now that with our balloon program, our patients do not just lose weight. They can actually gain muscle mass in parallel.
One study indicates that our patients will actually pick up 5% in lean body mass and muscle mass as they go through the Allurion program. This is vastly different than GLP-1 drugs, where 40% of the weight loss actually comes from muscle wasting. We believe that this is due in part to the whole program that we have put around the balloon that not only leads to weight loss, but metabolically healthy weight loss and better long-term results in the process. We've also now, after having treated 150,000 patients in the lifetime of the company, 100,000 patients in just the last three years alone, seen how Allurion fits into a very dynamic obesity landscape. We break the world out in terms of BMI. At the lower end of the BMI spectrum from 27-35, this includes patients who are overweight and have moderate obesity.
We really see our program as an alternative to GLP-1s. As I mentioned, one-third of our patients have previously tried a GLP-1 and growing utilization of our program in combination with GLP-1s in this BMI spectrum. At BMI 35-40, you enter class two obesity. These patients have higher weights, but also have more complex metabolic disease. In these patients, Allurion is a fantastic non-surgical option. As you may recall, 99% of patients who qualify for bariatric surgery do not get it, and they are looking for another option. It is a very rich population for us to explore. At even higher levels of BMI, class three obesity and higher, this is BMI greater than 40, o ur program can function as a bridge to bariatric surgery where patients actually get our program, lose weight, and then go on to have a much safer, less complicated surgical outcome. When it comes to providers, doctors who are actually placing our balloon in their clinics, we have a very clear value proposition for them. This is a bolt-on revenue stream for their practice. They are seeing patients with obesity who are coming off of GLP-1 drugs or do not want bariatric surgery. And for them, the Allurion program is a massive demand increaser. The balloon itself is so easy to use. There are no procedures involved. Most physicians can do this in their office without too much complexity. We help them actually build their practice around the program through in-clinic marketing.
We also provide our software suite to help them manage all of their patients going through the Allurion Balloon. Most importantly, this balloon is safe. Our risk profile is such that most physicians can do this pretty seamlessly in an office setting without any fear of serious complications. As I mentioned previously, the balloon does not act by itself. We have spent a lot of time at Allurion building a program around the balloon. Our patients actually get the Allurion Mobile App when they start their balloon experience. This syncs with the Allurion Scale, which we also give to patients. The scale, importantly, measures not just their weight, but their body fat, their muscle mass, their bone mass, all aspects of metabolically healthy weight loss. The patient app syncs with the scale, provides the patient with real-time analytics on their weight loss journey.
It also syncs with Apple Health and Google Health. If you do have a wearable, whether it's an Apple Watch or a Samsung Watch, we can bring that data in. We actually have developed a really rich data set that includes not just weight data, but heart rate data, exercise data, activity data, and sleep data. That informs our AI algorithms, and it also informs Coach Iris, which you see in the middle of this slide. Coach Iris is our 24/7 AI coach. It's always on, always attentive to whatever questions or needs the patient may have. It helps the patient go through their weight loss journey by preparing recipes, preparing physical activity plans, providing guidance on sleep and mental health hygiene as well, all 24 hours a day, seven days a week.
On the provider side, we provide something called Allurion Insights, which is part of the Virtual Care Suite. Allurion Insights is effectively a mini EMR for our clinics. It provides a snapshot of how all of their patients are doing with the Allurion program, providing real-time analytics. This is also where several of our AI algorithms live and provide real-time guidance and analytics to the providers to make sure that there are no patients who are falling through the cracks and not getting an adequate amount of weight loss. The results for the Allurion program, I believe, really speak for themselves. As I mentioned earlier, our patients lose on average 15% of their total body weight after just four months, which is vastly higher than what you can achieve with even significantly intense lifestyle intervention.
Second, and this is, I think, where we put most weight in terms of our views on our clinical data, 95% of the weight that our patients lose stays off one year later. This is not just a weight loss program. This is a program that helps patients change their lifestyle so that they can keep their weight off in the long run. As I mentioned previously, when our balloon is repeated, our patients can actually achieve over 20% total body weight loss after a year. These are all numbers that are right in line with the best outcomes that you can achieve with GLP-1 therapy. It is a vastly different type of option for patients who are looking to lose weight, especially lose weight quickly and keep it off. Our results also extend beyond just weight loss.
Patients with diabetes or prediabetes see significant reductions in their hemoglobin A1c after just four months. We actually can put diabetics into remission on average and ditto for prediabetics after just four months of therapy. Our balloon also impacts other comorbidities outside of diabetes. We have done several clinical studies looking at hypertension or high blood pressure, obstructive sleep apnea, triglyceride levels, cholesterol levels. These all correct in just four months after losing the significant amount of weight our patients lose, again, in a metabolically healthy manner while preserving and potentially increasing muscle mass. From a safety perspective, our balloon, we believe, again, is truly best in class. The shape of the balloon is such that it conforms to the volume and shape of the stomach.
The balloon is made from a proprietary polyurethane film, very thin, very flexible, very smooth, very different than the rigid silicone used in previous technologies. The balloon itself is just designed to be very gentle on the stomach lining because it is spending four months inside the patient's stomach. When you compare our rate of serious adverse events, and these are from U.S. FDA clinical trials, to other intragastric balloons, it's a night and day difference. Our SAE rate is two times lower than other liquid-filled balloons. Our intolerance rate is seven to eight times lower than other liquid-filled balloons. This is a real game changer for not just patients, but also the providers who are placing these balloons in their clinics. It's this risk profile that allows us to grow as quickly as we have. 2024 was no doubt a challenging year for Allurion.
We saw a lot of shifts in the obesity space due to the rise of GLP-1s. GLP-1s impacted various aspects of our business from just being a competitor in the space, but also increasing the cost of customer acquisition. In 2024, we pivoted away from pretty expensive and inefficient DTC marketing, especially with the rise of GLP-1 drugs where all of a sudden there was a lot more competition in that marketing channel. We pivoted more towards a B2B2C marketing strategy, which I'll go into in a few slides. We also had a temporary suspension of the product in France, which we have now resolved as of February of this year, which hurt our sales in 2024.
We also encountered some macroeconomic headwinds, especially in Latin America and other international markets, which led to starting 2024 with high levels of inventory that we have now destocked and depleted with the start of a new year here in 2025. Despite all of that, 2024 saw several accomplishments for the business. We actually grew our procedure volumes year over year from 2023 to 2024 by 4%, despite all of the disruption from GLP-1s. What we actually saw at the end of 2024, in the regions that were hit hardest by GLP-1s, we saw the most growth in procedural volume. That really just provides another data point that validates our positioning as a potential second-line therapy to GLP-1 drugs.
We also pivoted our commercial strategy away from a very expensive and inefficient, or what became inefficient, DTC marketing strategy to something much more profitable and sustainable that's B2B2C focused and really focused on organic demand generation at the clinic level. We also launched a new digital product. With the launch of Coach Iris in the US, we began supporting patients on our digital platform who didn't even get the Allurion Balloon. We began supporting GLP-1 patients, bariatric surgery patients, and we hope that this is a new business line that can continue to accrete top-line revenue for us, having nearly doubled in 2024. We started 2025 very early in January with the announcement of positive FDA trial data, a readout that we believe paves the way for completion of our PMA and eventually FDA approval.
Overall, in 2024, from a financial perspective and a procedure volume perspective, revenue did decline year over year, but procedural volumes actually went up. That's indicative of the destocking and depletion of inventory that we were able to achieve in 2024. We also right-sized the business in 2024, having reduced OpEx by approximately 50% year over year. All in all, I think the key takeaway for 2024 was growth in procedural volume, indicative of underlying organic demand for the program and our ability to achieve that at a much lower expense base, bodes very well towards our path to profitability, which really starts here in 2025. In 2025, we have five key pillars to the strategy.
The first is implementing a new commercial plan under new commercial leadership, which is already off to a fantastic start with the arrival of our new SVP of Commercial, Adrian Wild, who started at the company in August of 2024. We'll be setting the stage for EBITDA positive profitability for our ex-U.S. business in 2026 and plan to unlock even more efficiencies in 2025. We plan to complete our PMA submission this year, which should set the stage for FDA approval and a potential U.S. launch in 2026. We are also going to continue scaling our new business models, both the B2B side of our Virtual Care Suite, but also what we call Allurion Meds, which is our GLP-1 telehealth clinic that we launched in November of 2024 in the U.S. Our fifth goal was to resume commercialization in France, which we can now check off the list.
We were cleared for sales in France in February of this year. Let's just double-click on those five different pillars. The first is around our commercial strategy. Our old commercial strategy, as I mentioned, was very focused on DTC marketing, very focused on a transactional sales approach where leads were generated, balloons were placed, and a sale was made, and not much of a longitudinal relationship with the clinics that we were working with. We went very wide and built a pretty substantial sales force and distribution footprint. We were forecasting our business based on the conversion rates from our DTC marketing, which turned out to be highly volatile once GLP-1s began to scale. Our new commercial strategy is much more, we believe, sustainable and profitable. It focuses on B2B2C marketing at the clinic level, shifting away from the DTC marketing we were doing previously.
It's a much more consultative approach where we're focused on driving account-level demand generation and also growing utilization rates at the account level. We've also narrowed our footprint. We've actually exited certain markets that were small and unprofitable, and we're doubling down on our direct markets and specifically the channels in those direct markets that are core to us. That's really the bariatric surgeon and the gastroenterologist. We're very focused now on organic demand generation and creation at the account level, again, with a deep focus on utilization rates at individual accounts. When it comes to our path to profitability, we've taken great strides. Starting in 2024, with the reduction of our operating expenses by approximately 50% for 2024, we expect to reduce OpEx by another 50% in 2025, bringing our burn down again to half of what we burnt in 2024.
That will allow us or really set the stage in 2026 to get the ex-US business profitable as we prepare for a very exciting potential launch in the United States. By extending our runway through this restructuring and through some of the financings that we have recently completed, we now have the cash to not only set the stage for profitability, but also complete our PMA submission and potentially get the FDA approval and launch the product in the US in 2026, two major milestones upcoming for the business. Our path through the FDA is really facilitated by the positive top-line data that we reported out in early January. The Audacity FDA Pivotal Trial was a randomized controlled study looking at patients who got not just one, but two cycles of the Allurion Balloon compared to moderate intensity lifestyle modification.
It is important to note in this study, there was just the balloon. There was no AI platform, no behavior change program, no lifestyle modification program. This is just focused on the efficacy of the balloon. What we saw was really fantastic results in terms of responder rate. Over 50% of our patients lost more than 5% of their total body weight at 48 weeks, so at a full year of therapy. This is really the benchmark that FDA uses for clinically meaningful weight loss. We also saw at 40 weeks and 48 weeks a difference in total body weight loss of 4.2% and 3.7%, respectively. At 40 weeks, we actually saw a super superiority margin of over 3%, which again is FDA's benchmark for clinically meaningful weight loss over a control group.
We were thrilled with the SAE rate, the safety profile of our balloon coming in at 3.1% versus almost two to three times higher with previous intragastric balloons. I should mention that this is the first study with liquid-filled balloons that was done with multiple balloon cycles. We were able to show a positive safety profile better than previous intragastric balloons while exposing patients to two balloon cycles versus one. What we are really excited about here is the potential on the commercial side of our business, where with the launch of the product in the United States, we will effectively double our total addressable market. The United States is truly potentially one of the biggest markets in the world for a product like this.
In terms of the actual pathway through the FDA, I've touched on our PMA submission expected this year and potential FDA approval and US launch in 2026. We are already beginning to explore various models for how the Allurion Balloon will be distributed in the United States. It could take on the form of a direct sales approach, which mimics what we've been able to achieve and roll out outside the United States. We are also exploring a hybrid model that looks at a combination of direct and distributor approaches, and also a strategic partnership or licensing model where we can leverage existing sales forces that are calling on the same channels that we have had the most success with outside the United States.
It is a great boon to be able to start planning out a potential US launch and thinking about some of these models now that we have the FDA trial data read out. Finally, we are going to focus in 2025 a bit on scaling some of these new business models that we have launched. On the digital side of our business, we have two different models. One's a B2B approach where we actually sell software to clinics and to providers in a SaaS model. What we have found is that our software is actually very useful for clinics to manage all sorts of weight loss therapies, whether it's GLP-1 drugs, bariatric surgery, our balloon, or another balloon that the clinic may be using. We sell this software as a SaaS product. It's a recurring revenue stream for us, which we really like.
It leverages our Coach Iris AI coach and 24/7 platform, allowing patients to continuously get guidance no matter what therapy they are undergoing. We expect revenues from this software side of our business to double in 2024 and continue to increase in 2025. What this does is also allows us to enter the U.S. market and start building relationships with obesity management practices in the U.S. well before our balloon actually gets approval to launch in the United States. Similarly, in November of last year, we launched Allurion Meds, which is a GLP-1 telehealth service that leverages our entire digital infrastructure to actually prescribe GLP-1 drugs to patients in the United States.
Unlike some of the alternatives that are out there on the market today, our program comes with 24/7 coaching with all of the behavior modification and lifestyle change that we have perfected outside the U.S. We are now bringing that to GLP-1 patients here in the U.S. Our goal with this is not to really compete with Ro and Hims & Hers and all of these other digital outlets that are pumping ungodly amounts of capital into acquiring customers. What we are really doing is moving into the U.S. market, building relationships with patients who are interested in GLP-1s and weight loss in general, with the hope that those patients come on our platform and maybe one day are interested in getting the Allurion Balloon as a second-line therapy.
This, again, allows us to almost land and expand in the US well before our balloon gets FDA approval. In summary, I spoke a lot about what the old Allurion looked like in this presentation. It was a business that was growing at a very rapid pace, faced several headwinds with the rise of GLP-1s, which led to high burn, lower efficiency, a pretty DTC-heavy commercial strategy that became inefficient, very focused on our international business and just focused on our balloon. We have really matured into a business that has a much clearer path to profitability, has a brand new commercial plan under new commercial leadership, which is showing signs of traction already.
We have become a true global business with the launch of some of these new business units in the US with not just a balloon, but a holistic program built around that balloon that has a few offshoots in and of itself. In terms of catalysts, what to look forward to, certainly our path to profitability and our continued execution this year towards that path will be something I know a lot of folks are focused on, the rollout of our new commercial plan, US regulatory milestones, including the PMA submission and potentially an FDA approval, and then new proof points in our clinical pipeline that is going to test the combination of Allurion plus GLP-1 therapy, which could be a real game changer for the entire weight loss space and could actually create a new gold standard for how patients go through their journey to lose weight.
That is all I have today. Thank you very much for listening.