Good morning, and welcome to the Fractyl Health Commercial Strategy Day. At this time, all attendees are in a listen-only mode. A question and answer session will follow the formal presentations. As a reminder, this call is being recorded, and a replay will be available on the Fractyl Health website following the conclusion of the event. I will now turn the call over to Brian Luque, Head of Investor Relations and Corporate Development at Fractyl Health. Please go ahead, Brian. Good morning, everyone, and thanks for joining us. I am Brian Luque, Head of Investor Relations and Corporate Development at Fractyl Health. Today is our commercial investor day. Our purpose this morning is to walk you through how we intend to commercialize Revita, our investigational procedural therapy for post GLP-1 weight maintenance, assuming we are successful in our pivotal trial and in our regulatory submission. Before we begin, I will turn to the legal disclaimer. During this presentation, we will be making forward-looking statements, including statements about the timing and results of the REMAIN-1 pivotal cohort, our regulatory strategy and the potential use of the De Novo pathway, coding, coverage, and payment, the timing and content of a potential commercial launch, our expected financial performance, the potential sales and estimated total addressable markets currently and in the future for our product candidates, the potential timeline for profitability following the launch of Revita, and our cash runway. These statements involve risks and uncertainties that may cause our actual results to differ materially. A discussion of those risks is included in our filings with the SEC, including the Risk Factors section of our annual report on Form 10-K for the year ended December 31st, 2025, filed on March 24th, 2026, and our quarterly report on Form 10-Q for the quarter ended June 30th, 2026, filed on August 10th, 2026, which I encourage you to review. Forward-looking statements speak only as of today's date, and we undertake no obligation to update them. I want to be clear about two things at the outset. Revita is an investigational device. It is for investigational use only in the U.S. and a CE mark in the E.U. and the U.K. FDA pre-submission feedback is advisory and non-binding, and there is no assurance that the FDA will accept a De Novo marketing application or that Revita will receive marketing authorization. The REMAIN-1 study database has not been locked, as this is an ongoing study, so the data are subject to further cleaning and validation. You will be hearing from four speakers this morning. Dr. Harith Rajagopalan, our Co-Founder and CEO, will start with the problem we are solving, the opportunity, and the evidence we have generated thus far. We are then delighted to be joined by Dr. Folahan Ayoola. Dr. Ayoola is a medical director of bariatric surgery at Texas Health. He will give you the view from inside a metabolic practice on the unmet need in post GLP-1 patients. Mike Zumdahl, our Senior Vice President of Market Access and Commercial Strategy, will then take you through our Center of Excellence strategy and our market access plan. Mike joined us in June from Inari Medical where he built global reimbursement and health economic infrastructure for a breakthrough procedural therapy through its acquisition by Stryker last year for nearly $5 billion. Lara Smith Weber, our Chief Financial Officer, will close with the commercial model and the path to profitability. Following prepared remarks, we will be happy to take your questions. With that, it is my pleasure to hand it over to Harith. Thank you, Brian. Good morning, everyone. In July, we shared one year randomized data from the REMAIN-1 midpoint cohort and why we have conviction in Revita for the large post GLP-1 weight maintenance opportunity. Today is a different conversation about the potential market opportunity for Revita in post GLP-1 weight maintenance. Six key points. The unsolved problem in obesity is now maintenance, not weight loss, and there is no approved off-ramp. We have randomized and open label data showing a durable signal with six-month top line from the 300+ patient pivotal cohort expected in early Q4. That study is built to support a potential De Novo filing in latent Q4 on a Class II path. The commercial build is activation, not market creation. The payment work is already in motion, and we believe a focused Center of Excellence launch can reach profitability five to eight quarters after launch. Let me start with the problem. There are roughly 29 million people in the U.S. on a GLP-1 for weight loss today. These drugs work. They have changed what patients and physicians believe is possible. But look at the curve on the right. This is Lilly's SURMOUNT-4 study of tirzepatide discontinuation. Patients lost about 20% of their body weight during the lead-in. Those switched to placebo went straight back up and were still gaining at one year. That pattern has been consistently seen across studies, with almost all weight regained by around 18 months. Because patients regain fat faster than muscle they lost, body composition worsens on the way back up. To a patient, the consequences are severe. Not only weight regained, but also metabolic rebound and the psychological turmoil of having lost the weight and then gained it all back. Roughly 85% of patients regained the weight they lost. There is no FDA-approved therapy for post GLP-1 weight maintenance. As newer drugs become more potent and more accessible, we believe that gap will only widen. It is estimated that over 1 million patients discontinue a GLP-1 each month in the U.S. The pattern is consistent. Initiation, weight loss, then discontinuation driven by costs, side effects, or access, and then rapid regain, with two-thirds of the lost weight back within a year of stopping. This is a systemic pattern, not individual failure, and it is the single largest unaddressed problem in obesity care today. Let's consider a typical GLP-1 patient. She lost nearly 50 lbs on a GLP-1, but her weight loss has plateaued, and she wants to recover the energy to sit on the ground and play with her grandchild. She asks her physician, "Do I have to stay on this forever? Will the weight come back?" Unfortunately, today the answer is yes. There is no durable non-drug off-ramp. Revita is a single one-time outpatient endoscopic procedure that ablates the duodenal mucosa like LASIK for obesity. The duodenum is where nutrient sensing goes wrong after chronic high-fat, high-sugar diets, and Revita is designed to ablate that damaged tissue and allow healthier mucosa to regenerate. Revita holds FDA breakthrough device designation for weight maintenance in patients discontinuing GLP-1 therapy. It is designed to complement lifestyle changes and pharmacology, not replace them, and it is protected by a robust IP portfolio covering thermal and non-thermal ablation approaches. The catheter is placed through the mouth over a guide wire while the patient is asleep, and the length of the duodenum is treated by a repeated sequence of circumferential saline lift and then precisely controlled hydrothermal ablation at each lift site along more than 14 cm of postpapillary duodenum. There are a few aspects of this procedure that make it a potentially scalable option for a broad population and attractive to physicians. First, the procedure uses skills an advanced endoscopist already has. Second, and critically for patient acceptance, it does not alter the patient's structural anatomy. Nothing is resected, implanted, or sutured, no restriction is created, and patients go home the same day. Third, it does not close the door on any other option, from diets to drugs to other procedures. Our clinical program is a stepwise validation run under a single IDE built to support a potential De Novo submission late in Q4 of this year. Three cohorts. REVEAL-1 is our open-label real-world cohort. One-year data came in Q2. The midpoint cohort is our randomized, double-blinded, sham-controlled pilot of 45 patients with a tirzepatide run-in, randomized two- to- one. We reported one-year data in July. The pivotal cohort is the same design, the same population, and the same investigators at over 300 patients. Here's what those first two cohorts have shown. REVEAL-1 open-label real-world data set, 22 patients enrolled who had already lost at least 15% total body weight on a GLP-1 and wanted to come off. At one year after a single Revita procedure, participants retained approximately 78% of the total body weight loss achieved on their GLP-1. That is open-label, real-world data. But what does it look like in a randomized setting? In the midpoint cohort at one year, up to 84% of GLP-1-induced weight loss was retained with Revita, versus 46% with sham in patients who received complete duodenal ablations. The pivotal cohort is the box on the right. Topline six-month data early in Q4 expected. Topline one-year data in the first quarter of 2027. As an illustrative example from the midpoint cohort, a participant spent five months on a GLP-1 and lost 44 lbs. Then the drug was stopped. One year later, with no GLP-1, a sham patient is back up at 199 lbs on average, regaining 23 lbs, holding on to less than half of what she lost. The Revita patient is at 184 lbs. She has regained only eight pounds. These are mean results in the complete ablation population. We will soon see how these results translate when we read out our pivotal cohort in early Q4. Safety is the other half of the story. Through 12 months in the midpoint cohort, there were no device-related serious adverse events, and all four related events were Grade 1, occurred on the day of the procedure, and were transient. We have never seen a late adverse event from Revita. This is a mild periprocedural profile. It is consistent with prior studies of Revita, and it is what we believe supports outpatient use at scale. Now to the pivotal. Adults with obesity, BMI 30-45, GLP-1 naive, without type 2 diabetes, randomized two- to- one, Revita versus sham, double-blind, sham-controlled, tirzepatide administered to achieve at least 15% total body weight loss and then discontinued. Diet and lifestyle counseling runs throughout the study. Two co-primary endpoints. Percent total body weight regain versus sham at six months, and a responder rate, the percentage of participants who maintain at least 5% total body weight loss at 12 months. The most important thing about this study is how closely it mirrors the midpoint cohort you just saw. Same design, same population, same enrollment criteria, same investigators, same protocol in a larger, well-powered forum. Both co-primary endpoints are very well-powered for pivotal success. On the first co-primary, percent total body weight regain at six months, our base case is a sham regain of 11.6%, against which Revita would need to come in at or below 9%. What we observed in the midpoint cohort was 5.1%, a meaningful, statistically significant reduction in regain in the Revita arm versus sham, particularly in participants with longer ablation lengths or higher run-in weight loss, is what we believe a successful readout looks like. On the second, the responder rate, the pre-specified performance goal agreed with FDA is 50% of patients maintaining at least 5% of their total body weight loss at 12 months. In the midpoint cohort, that figure was 73% in the intent to treat population and over 90% in the complete ablation cohort. These are model-based estimates from an exploratory analysis of the midpoint cohort, which was not powered for formal inference. Now turning to regulatory. We received favorable pre-submission feedback from FDA in March. The agency indicated that the safety profile of the Revita DMR system is consistent with a Class 2 De Novo device classification. Final determination on regulatory path will be made once the FDA has the opportunity to review the safety data from the pivotal study. We are optimistic about the De Novo pathway. We see one pivotal study as a registrational package, and a successful De Novo makes Revita the reference device for the category, creating the predicate for future 510(k)s under defined special controls. We intend to begin our De Novo marketing application in late Q4 2026. Assuming the pivotal data are favorable, we believe we will be in a position to submit the regulatory package. Let's walk through its timeline and milestones. After we file, there is a short acceptance review, then substantive review, with the clock stopping while we respond to FDA's additional information requests. Then, post potential clearance, roughly four months of launch preparation, the transitional passthrough application, hospital contracts, console placement, and initial physician training happen during that time. This is illustrative. These durations are our assumptions, not FDA commitments. The timing of passthrough coverage and launch is not assured, but it governs our planning, and it is why we feel urgency to do the commercial preparation now. The post GLP-1 weight maintenance opportunity is large, urgent, and a white space. Step one is what we are proving out now, maintenance after GLP-1, an off-ramp that preserves weight and metabolic benefit after discontinuation. Beyond that, we see further opportunities consistent with where physicians themselves see unmet need, which is why we believe Revita can become a backbone therapy in obesity. With that, I would like to turn the microphone over to Dr. Folahan Ayoola. Dr. Ayoola is Medical Director of Bariatric Surgery at Texas Health in Flower Mound, north of Dallas. He is a fellow of the American College of Surgeons and of the American Society for Metabolic and Bariatric Surgery, and he runs an accredited metabolic program managing large panels of patients on GLP-1 therapy and patients considering procedural intervention. We asked him to speak to the perspective of a practicing physician who sees this problem every day. He has no financial relationship with Fractyl and no prior involvement in our clinical studies. I would rather you hear about it from him than from us. Dr. Ayoola? Thank you so much for that introduction, Harith. Good morning, everybody. Glad to be here. As Harith said, I am a bariatric surgeon. I'm here in North Texas, D.F.W. Metroplex, and I run a comprehensive bariatric program. What that means is we do lifestyle changes with diet and exercise. We prescribe medications, whether IV, GLP, or subQ GLP, or pills. I also do surgery. I perform all operations, sleeve gastrectomy, gastric bypass, duodenal switch, et cetera, and I've been doing that for about 14, 15 years now in North Texas. The program that I run at the hospital is a center of excellence, has been that for 10 years. I built that program De Novo at that hospital, and we're very proud of the work we've done over the last 10 years. In my practice, we were performing anywhere from 300 to about 350 cases a year, which is typical for a busy private practice surgeon in D.F.W. About 45%-50% of my cases were sleeve gastrectomy, about 45% were duodenal switches, and the rest were gastric bypass cases. This is relevant because, excuse me, when GLP came out, the cohort that suffered the most or you saw go away were the sleeve cases. For me, almost 50% of my volume was gastric sleeve, and that was what kind of disappeared honestly once the GLP medications became mainstream. I went from about 300+ cases to about 150+ cases. I know my colleagues that only did sleeve gastrectomies basically went out of business insofar as bariatric surgery was concerned. They had to find something else to do. That is the impact GLP medications have had on our discipline. You saw that as well nationally. Procedures fell from 270,000 in 2023 to below 200,000 in 2024. Some programs actually closed up because of that. We see that trend continuing. Patients today that come in want GLP medication. I have about 2,000 patients on my panel alone. We will see about 50 patients every week coming in for GLP drugs and maintenance. That is certainly something that is continuing. The problem is when I speak to patients early on and they say, "I hear about these medications. I would like to get on them," when I tell them that they have to stay on it for life to maintain their weight loss, some of them actually have their faces drop because they really did not come in expecting that. They think they are going to take it, cure their obesity, and be able to move on. When I tell them that is not what the facts bear out, some of them do not believe me. They are in denial. They just think they are different. They are going to take the meds, they will be cured, and they can come off. As you would expect, I see problems in the future for those patients that believe that. Some of them walk out and say, "Well, I do not want a temporary solution to my weight. I want a more permanent option." I offer them surgery. Some will take me up on that, and others do not. Very few understand this is something they would have to take lifelong if they want the benefits. Most patients really just want to break the chains of being on weight loss drugs forever. They want to lock in the success of the GLP medications once they achieve their goal weight. This is why I got excited about Revita the first time I heard about it, because it really does address a significant need. GLP patients on GLP drugs really want to lock in the weight that they have lost. We know that it being an endoscopic procedure, we have the capacity to do 400- 500 of these procedures a year once this is approved. We already have the endoscopy suite. We already have fluoro. We already have all these things ready. We already have the patients that are interested. Things are already set up to really segue into this. I got really excited when I saw it. The other thing is, I feel like the same way GLP medications reduced our surgical volume but actually increased our overall clinic volume, is the same way I think Revita has the potential to have more patients actually start the GLP-1 drugs, the ones that would have walked away, and more patients turn into this. If you think about it, the data says 40% of U.S. adults are obese. That translates into, I believe, 100 million people. When you look at our surgical numbers, we are doing 200,000 patients procedures a year. We are doing 0.3% of the volume we would need to do. We always joke about how if every bariatric surgeon operated 24/7 every single day, every year, we do not have enough surgeons to actually scratch the surface of the problem. The problem wasn't getting better, it was actually getting worse as the trajectory kept increasing. It's only plateaued recently with the GLP-1 medication being so mainstream. I think when you lock something like that in with Revita, you also now have the option and the opportunity to not only plateau this problem, but start pushing it back down, which will be the first time we've ever done that in decades. So, it's not an understatement to say if everything pans out, this is very exciting and a great opportunity for our patients. Again, it's not a trade of your surgical volume. It's really expanding what we're doing. As surgeons, we've been trying to get people to have surgery and take care of this problem, but people just push back. They're afraid of surgery. So having something that's endoscopic, not altering, I think will be more palatable for a lot of people and has the opportunity to grow our treatment options in treating patients suffering with obesity and struggling with this problem. Again, I'll close with the fact that what we need now once this is approved, is training on it, coverage from insurance and so on, and looking at our scheduling capacity and expanding that to incorporate this procedure into our practice. I think it does have a really great place in the management of obesity. With that, I will turn back over to Harith. Thank you. Thank you, Dr. Ayoola. We may get some questions for you later on, so would appreciate you staying on the line. Over the years of our development, we've gotten to know many physicians like Dr. Ayoola who face a similar unmet need for their patients, managing individuals who are coming to them because they are on GLP-1s or actively looking for alternatives, don't have an off-ramp today, don't want surgery, but also don't want to stay on the medicines for life. These physicians possess not only the patients and their panels, but also the necessary procedural skills and infrastructure for Revita. Mike, over to you to discuss how we plan to fulfill this present market need in their practices. Thank you, Harith, and thank you, Dr. Ayoola. I joined Fractyl in June from Inari Medical, where I spent over five years building global reimbursement and health economic infrastructure for breakthrough procedural therapies. I have seen what makes these launches successful and how reimbursement and market access are integral components of a targeted and efficient center of excellence commercial strategy. I believe Revita has an unusually favorable profile for a new market entrant. Most new device launches are market creation exercises. You have to find the physician, convince the physician, build the service line, create the referral pattern, and then teach a hospital how to get paid. That is a time-consuming exercise, and it is expensive. Revita's opportunity in post-GLP-1 weight maintenance is not that. This is a potential market activation and market fulfillment built on several tailwinds in the market. There are four things that we have to do, and all four of them start with an existing base of relationships we already possess. Number one, open high-quality centers. These high-volume metabolic centers already exist today and are built for Revita. Number two, select appropriate patients. Highly motivated GLP-1 discontinuers are already sitting in these interventionalist clinics. Patients, many of them do not want to remain on a GLP-1, but they also don't want to have anatomy-altering surgery. Right now, there is no alternative. Number three, perform great procedures. We leverage an existing interventional skill set that is commonly held among these metabolic interventionalists and a validated training program from our clinical development program that has already demonstrated consistent outcomes and technical success without significant safety concerns. Number four, secure payment. This must align with the health economics for patients, providers, payers, and for Fractyl. Let us walk through each of these in turn. The post-GLP-1 opportunity is massive, no matter how you slice it. Roughly 29 million U.S. adults are on a GLP-1 for weight loss, and that is from Gallup 2026, which is about 11% of the 262 million adults in the U.S. There are similar estimates from the Kaiser Family Foundation as well backing this up. Of those, about 65% discontinue within 12 months, and that is from the JAMA Network Open real-world persistence data that Harith referenced. That gets you to about 18.8 million people per year. Of those, we modeled 30% as having achieved at least 15% total body weight loss before they stopped. That is our base case, and it comes out of a Monte Carlo simulation with existing agents in the market today. That gets you to about 5.7 million. The eligibility on label BMI 30- 45 takes about 70% of that, which is about 4 million eligible patients per year. At a procedure price between $10,000 and $30,000, that is a $40 billion-$120 billion total addressable market. This TAM frames the size of the opportunity. Now let us get to how we access it. Our two primary constraints are how fast we can activate centers and how quickly we can establish broad coverage. Dr. Ayoola just described his ASMBS certified center of excellence from the inside. He has almost everything he needs. Comprehensive metabolic program. He already manages thousands of GLP-1 patients, many of whom do not want to stay on a GLP-1, but also don't want bariatric surgery. He has obesity medicine and APP in his practice who extend his reach. He has nutrition and lifestyle counseling on staff. He controls the necessary prior authorization machinery to work through reimbursement coverage. He has ample endoscopy and fluoroscopy suite time because his bariatric surgery volumes have been negatively impacted in the last several years. He's spent his career developing the interventional skill set and the interventionalist mindset. He's an ASMBS Center of Excellence, and he has the clinical infrastructure to support post-marketing registry participation. All of this infrastructure exists today in hundreds of centers, just like Dr. Ayoola's all across the U.S. Now look at the right column. What's missing? One item, an approved, reimbursed, durable off-ramp procedure that enables patients to make the progress that they're trying to make in their obesity journey after GLP-1 induced weight loss. That is the whole thesis. We are not building a market. We are supplying the one missing component to a market that's already been built, staffed, and accredited by the medical societies. We are planning to target and focus on a center of excellence launch into centers just like Dr. Ayoola's. There are roughly 1,000 accredited centers across the U.S. listed on the ASMBS website. This is a concentrated, geographically identifiable footprint, and it overlaps heavily with the metropolitan areas where post-GLP-1 population is densest. Our early launch targets the top 10%- 20%, or roughly 100- 200 centers. The first wave includes our own REMAIN-1 clinical sites and established centers of excellence where we already have relationships with the physicians. The reason this matters commercially is that this is a nameable list. We know who they are, and we can call them by name. We won't be targeting all of these centers right from the start. We intend to go deep before we go wide. The first phase in year one, 30- 50 of the highest readiness centers of excellence, trial sites, and centers we're already in dialogue with. The work in phase 1 is training, pathway integration, and economic proof. We need these sites to run the procedures well and to get paid, and we need to continue to build real-world evidence that will kickstart the flywheel for broad coverage and label expansion opportunities. Next, in year two, we expand to 60- 90 centers. The early sites become regional training and referral hubs. This phase is replication of a proven pathway as we grow within geographic footprints defined by our commercial field sales organization. Then in year three and beyond, we expand to 100- 200 centers, at scale representing 10%- 20% of the potential center distribution. Broader rollout as the procedure becomes routine and coverage solidifies. When I was at Inari, we launched at many more centers in the span of this time than what is contemplated here because there are fewer VTE patients, and they are not as readily accessible as the GLP-1 discontinuers. We believe that we are modeling for post GLP-1 weight maintenance as conservative and achievable, but allows us to have high touch in early launch focused on the clinical success and key proof of Revita's value to the market while generating substantial revenue, which Lara will cover shortly. Now let's discuss the physicians at these centers. Our customer is the metabolic interventionalist, a proceduralist who already treats obesity with procedures and who also manages these patients in clinic. Some of them come from advanced GI endoscopy, like Dr. Thaker, who joined our data call in July. Some of them, like Dr. Ayoola, come from bariatric surgery. We estimate that there are between 300 and 400 GI endoscopists with active bariatric practices and 2,000- 3,000 bariatric surgeons. These are company estimates of the addressable operator pool, and they align with publicly available information on metabolic interventionalists and bariatric and metabolic procedural expertise. Three things follow from that. First, these physicians already have the patients in their practice who are seeking new options for their obesity. These physicians understand the patients and their wishes and can have what I believe is to be the first truly informed, shared decision-making conversation with these patients about their treatment options and obesity across the continuum of care. When you ask a prescriber, such as an endocrinologist, about weight maintenance, you get a prescriber's answer, another script managed for life. Our customers with the patient sitting right in front of them is asking a different question. Not which medication comes next, but how do we fix the root problem and let the patients go on with their life? They already have incorporated GLP-1 management into their comprehensive practices over the past several years. These patients are actively looking for an alternative to lifelong GLP-1 meds, but they don't want something viewed as anatomy altering. Second, interventionalists are not clinically but also economically motivated, with expected revenue per physician that is high and recurring. Third, this is the commercial build consequence. This is a finite and nameable target list of physicians to get to know and to train. They all know one another intimately, and they reference one another in their buying decisions. Revita's medical education opportunities are already growing simply through word of mouth among these interventionalists. These features support a highly efficient field force of tens of people, not hundreds. We are excited by what we're hearing about anticipated volumes per center according to these physicians. 100- 200 initial target centers, we estimate more than 2,000 GLP-1 patients per center per year already sitting in these practices. We believe roughly 50% of patients should be keenly interested in an off-ramp, and 250- 500 Revita procedures per center per year as they ramp their service offering. Note that physicians tell us they have ample time and procedure suite or OR time to perform these procedures as well. Our own modeling suggests that each center has current capacity for over 1,000 Revita procedures a year, so we are still well within the institution's capacity constraints. If a center has 2,000 GLP-1 patients a year and 250- 500 of them convert to a procedure, that's a conversion rate in the low double digits off a panel of patients that the center already owns. We believe that that's a reasonable and conservative assumption that we're modeling, and it's the reason a small number of centers can support a meaningful business on its way to profitability. In the REMAIN-1 trial, the interventionalist training requirement was a half-day didactic session, plus approximately four cases with a Fractyl clinical specialist to reach physician and staff proficiency. Protocol-defined technical success is complete ablation of the entire duodenum, more than 14 cm covering the postpapillary duodenum. That is a measurable endpoint, which our console measures and records, which means proficiency and standardization are something that we can verify objectively. We have the infrastructure for training already built. Site training forecasts, equipment, procedure supply lists, room layout, procedure workflow overview. This is not something we will develop after authorization. It exists and has been validated through our pivotal program across our trial sites and through independent testing with physicians who are new to the procedure. This validated training program is one component of our De Novo authorization application, and it is ready to go now. We walked through the opening centers, selecting patients and performing procedures. Now on to securing payment, which is where I focus much of my time today. Coding, coverage, and payment are the three different aspects of reimbursement and market access, with three different decision-makers and three different clocks. Let us look at each one. Coding. Coverage and coding. We filed a CPT Category III application in June. We anticipate the code going into effect in 2027, and that is ahead of our potential marketing authorization. Coverage. On the Medicare side, we intend to leverage breakthrough device designation and CMS' clearly stated desire to accelerate coverage for breakthrough devices formerly through the TSAT and now the new rapid pathways to aim for early national coverage aligned in timing with FDA authorization. We believe our argument here is strong given that CMS existing coverage for GLP-1s and existing national coverage for bariatric surgery. On the commercial side, medical policy will be informed by our value dossier and our health economics work. We plan third-party prior authorization and appeal support to our centers and facility to facilitate early coverage with commercial payers. Lastly, payment. On the facility side, potential transitional pass-through, or TPT, to make hospitals whole on day one. On the physician side, professional payment will be established through CPT valuation over time. Just remember, CPT, ambulatory payment classifications, and pass-through outcomes are subject to the American Medical Association and CMS review cycles and are not assured. All three tracks are moving now, and the sequencing underway on each of these three is something I have deep expertise with from my prior roles. Here is why I am not as worried about the fundamental question of whether payers will pay for an obesity procedure. They already do. UnitedHealth, Elevance Health, Aetna, Cigna, Blue Cross and Blue Shield of Illinois and Texas, or HCSC, that is roughly 120 million commercial lives among them. Every one of them covers bariatric surgery today. Every one of them covers GLP-1s for obesity with either a prior authorization or an employer opt-in. CMS, with roughly 68 million beneficiaries, if you include Medicare Advantage and regular original Medicare, covers bariatric surgery under a national coverage determination and is now covering GLP-1s for obesity through the Bridge program, which went into effect on July 1st. That is nearly 200 million lives that sit with these six payers already reimbursing bariatric surgery. We expect these precedents to provide the roadmap for coverage decisions for Revita over time. Those are the tailwinds. We are not asking a payer to accept a new category of spend. We are asking them to accept a new, lower-cost, one-time entrant into a category they already fund on both the drug side and the procedure side. We have been engaged with CMS all through our journey and are continuing to engage actively with private payers as the coverage landscape evolves and as we approach the market. To that end, we are planning a registry to build the kind of real-world evidence that payers need to adopt and pay for new technologies. We already have around 50 patients with one year of follow-up from REVEAL and the REMAIN-1 midpoint cohort, and that number will be around 250 patients once the pivotal study reads out. The FDA has granted a protocol amendment to allow us to gather longer-term data as well, and we plan to roll all of this into a prospective registry to develop more real-world evidence over time. I would like to spend a moment specifically on Medicare because something has changed this last year that is a significant tailwind for our opportunity, and I don't know that it's well understood yet. The two key features are the GLP-1 Bridge program and the Transitional Pass-Through, or TPT payment pathway. The Medicare GLP-1 Bridge program began on July 1st, and we estimate 4 million Medicare beneficiaries will access GLP-1s through it over the next 12 months. CMS has publicly said several million, but adoption has been quick, even in the last few months. The Bridge program is set to expire December 31st, 2027. Even the Congressional Budget Office estimates 65% will discontinue, even if the program does not expire. So 2 million- 3 million of these beneficiaries are expected to discontinue within a year. Of those, we estimate 600,000- 970,000 will achieve a deep response before stopping, which leaves an estimated 510,000- 830,000 CMS beneficiaries eligible for Revita and for Transitional Pass-Through on the basis of the CMS GLP-1 and bariatric surgery coverage for obesity with related comorbid conditions. Said another way, a federal program is in the process right now of creating and then time limiting the exact population that Revita is designed to serve. This is an unusual alignment and why our coverage strategy is starting with CMS. Commercial payers will ask us for cost-effectiveness, and we've begun our modeling with approximately 50 patients at one year that we already have against the interventions that already exist in the market and that they already pay for. The green band on the right is the payer's willingness to pay range, which is $100,000- $150,000 per quality-adjusted life year, or QALY. Anything to the left is generally considered to be highly cost-effective. Bariatric surgery sits at about $21,000 per QALY over a lifetime. WATCHMAN's left atrial appendage closure device at about $28,000, TAVR at $50,000, and MitraClip at $56,000. Percutaneous coronary interventions for stable angina is at $171,000 cost per QALY on the far right, which is in the poor value zone. GLP-1s for obesity at net pricing are at about $135,000 cost per QALY, right at the edge of that willingness to pay band. Revita, modeled at between $10,000- $30,000 ASP, sits to the left of every device intervention on this page. Revita can be highly cost-effective, even at the higher end of our modeling. Two caveats. The Revita value is our internal modeling. It's not peer-reviewed, and it is contingent on the durability that we will see in REMAIN-1. We used a Monte Carlo simulation of over 10,000 scenarios that assumed some attrition in Revita's effectiveness over time and assumed declining GLP-1 prices from their current net prices as well. I don't believe that we're being overly ambitious, but we will need more long-term data and to keep a close eye on the market to be able to model more precisely. These are cross-study comparisons, so populations, comparators, and time horizons do differ. Let me close by reminding you that there are four things that we need to do to be successful commercially, mapped to the four main roles that we plan to have in our commercial organization. To open high-quality centers, we intend to hire business development managers focused on new site selection and activation. To select appropriate patients, account managers focused on site execution, patient funnel, and procedural growth. To perform great procedures, we'll have clinical specialists focus on clinical excellence and outcomes. To secure payment, a team of health economics and market access people focused on payer engagement, prior authorization, and billing support. Before I joined the company, I was pleased to see that Harith and the team had already built an organization with ample experience in each of these first three dimensions through the execution of our clinical study, which required all of these skills to be put to use. We ran the REMAIN-1 study mostly in-house with our own personnel, precisely to develop the capabilities necessary to help us prepare for commercialization. Many companies rely on CROs for these functions, but these are skills inherent within our team today. As for the fourth of these capabilities, the Health Economics and Market Access, or HEMA team, is where my experience comes in. That is tens of people in the commercial organization over the next two to three years of ramp, not hundreds. We believe that it is possible because the target list is finite and nameable, because the physicians already own the patients, because medical education is spread via word of mouth, and because volume comes from depth in a small number of centers rather than breadth across thousands. That structure is what makes the economics work. Lara is going to take you through these economics now. Lara, over to you. Thank you, Mike. You've heard how this works, the center model, the patient, the procedure, the access pathway. My job for the next few minutes is to tell you what it's worth, what it costs, and when it turns profitable. Before I go to the model, I want to show you that this shape of launch has worked before. Inari, where Mike comes from, in venous thromboembolism, followed a center of excellence model, reaching more than 50 of about 200 targeted centers in year one, a 30% compound revenue growth rate in the launch years, and an exit to Stryker at $4.9 billion, about eight times sales. Shockwave in high volume PCI centers added 1- 1.5 new accounts per territory per month, reaching the majority of its target in about two years with 57% compound revenue growth rate and an exit to J&J at $13.1 billion, about 14 times sales. WATCHMAN, which Boston Scientific bought pre-approval, scaled past 700 programs and $1 billion a year under the commercial leadership of Fractyl Health's board member, Sam Conaway. What drove value for shareholders in all three cases is the same three things, a finite list of high volume centers, deep utilization per site, and strong growth. The indications were different, but the model was the same. That is the model we are describing to you today. On price, we are not disclosing a number today. What I can show you is the corridor the market has already established because payers are already paying at both ends. On the left, endoscopic sleeve gastroplasty. It has a CPT Category I code since January 1st, 2026, and Medicare pays roughly $11,600 in the hospital setting. On the right, bariatric surgery. Commercial and uninsured pricing runs $20,000-$33,000. Revita sits in the middle. It is outpatient and under an hour. There is no resection and no anatomic change, so it is repeatable and leaves no permanent implant. It targets the duodenum, which is a distinct mechanism from restriction. So the bracket is roughly $11,000-$33,000 set by procedures payers already reimburse. Unit economics have to work for providers and for Fractyl, and we believe they will. From the hospital's view, endoscopy and bariatrics are already major drivers of hospital contribution margin. Transitional passthrough enables a positive contribution margin from day one by passing the disposable cost through to CMS. There is no new capital footprint to justify because the rooms, infrastructure, physicians, and support already exist. One thing to highlight, because passthrough reimburses the device separately, the hospital's economics do not depend on our price. Our pricing is not a barrier to adoption. From Fractyl's point of view, potentially high gross margin on the disposable, capital light with no high cost, long lead times sales cycle per site, and commercial costs that scales with sites rather than linearly with volumes. The potential result is recurring high margin procedure revenue concentrated in high throughput centers. Which brings me to the ramp. We expect potential launch in early 2028. Centers lived cumulative on the left, 30-50 centers by the end of 2028, and 60-90 by the second half of 2029. Procedures on the right expected to grow to 5,000-10,000 annually in 2029. Two things worth noting about the shape. First, these are the same high volume centers you heard about earlier. Second, volume grows faster than the network does in year two. We expect to increase procedures per center as centers get up and running. The 2028 center cohort matures through 2029, providing meaningful growth. These are management estimates. They are contingent on pivotal results and on FDA marketing authorization, neither of which is assured, and they are not guidance. Now putting that all together with every input on one page so you can run it yourself. Price per procedure, $11,000-$13,000, which is the benchmark range we just walked through. $33,000, which is the benchmark range we just walked through. Gross margin of approximately 80% for the single-use catheter, in line with single-use peers. Note that we held the margin flat across scenarios to be conservative. Higher ASP may lead to quicker cash break-even than shown. Now solve for procedures at 80% gross margin and against a $22 million quarterly break-even cash burn. At a $10,000 ASP, we need about 2,750 procedures a quarter to break even. At $20,000 ASP, 1,375 procedures a quarter, not tens of thousands, and across a range of prices, potential cash break even is possible in 2029. Every one of those dates assumes De Novo approval in the second half of 2027 and CMS coverage and transitional passthrough in early 2028. They are contingent on De Novo authorization, on coverage, on financing, and they are not guidance. These are estimates only. Real-world results could vary. Let me put the whole sequence on one page. Today is our Commercial Strategy Day. Early Q4 2026, we expect pivotal six-month top line from the over 300-patient randomized trial. Late Q4 2026, potential FDA De Novo submission. Late 2027, potential FDA approval and launch preparation. Early 2028, U.S. commercial launch with transitional passthrough in place, and cash profitability expected in 2029. Potentially five to eight quarters from launch to cash profitability on a potential high gross margin disposable into a finite set of centers that already have the patients, the physicians, the rooms, and payer precedent for obesity procedures. These timelines are management estimates and forward-looking. Revita is investigational, and commercialization is subject to REMAIN-1 results and FDA marketing authorization, neither of which is assured. Harith opened the day with this slide. What I'd say is that these were six claims this morning, and you've seen what sits behind each of them. The unmet need, the durability data, the regulatory path, the centers, the payment work, and the economics. With that, I'll hand back to Brian for questions. Fantastic. Thank you. That concludes our prepared remarks. Operator, we're ready for questions. Thank you, Brian, and to all of our speakers. At this time, we will be conducting a live Q&A session. For covering analysts, please use the raise hand feature to be added to the queue. Kindly hold for a brief moment while we poll for questions. Our first question comes from Michael DiFiore at Evercore. Please go ahead, Michael. Hi, guys. Thanks so much for hosting this session today. Great presentation. Two questions from me. First, on pricing. I know you cannot disclose the price today, but the price of $10,000-$30,000 per procedure is kind of a wide range. You mentioned in your presentation that you need long-term durability data. Is that the main deciding factor in terms of where on that range the price may lie? Then I have a follow-up. I would say this, if the 50 patients that we have seen from REVEAL and REMAIN are any indication, we feel very comfortable across that range in pricing. We will be thinking through what this looks like once we have the full cohort from REMAIN-1 pivotal, which we have just announced will be a Q1 result. That we will put into our health economic modeling and then provide granular detail. I think the fact that there is a wide range of plausibility here shows that we can straddle from truly cost-effective for the market to- S orry cost-saving for the system, through to highly cost-effective across that entire range. Some of these choices are going to be dependent upon our data, and some will be dependent on conversations that we have with insurers. I see. Very helpful. My follow-up question is that you previously suggested that retreatment at 18-24 months or later would likely be acceptable. You also said that it may not be necessary for some patients or for many patients. I guess my question is, what percent of patients do you currently model needing a second procedure at two, three, or five years? Go ahead. Great question, Mike. Look, right now, the numbers that you've seen, those scenarios, I think it's page 40 for break even, none of those depend on retreatment. If you think about the 5,000- 10,000 annual procedures in 2029, that's about a tenth of a percentage point of the TAM of the $40 billion. Retreatment would be upside on that. Got it. Thanks so much. Thank you for your questions, Michael. Our next question comes from Angela Qian at Canaccord. Please go ahead, Angela. Hey, guys. Thank you for the presentation. Thanks for taking my question. Maybe one for Dr. Ayoola. Understanding the threshold for approval here is maintaining that 5% total body weight loss. From your perspective, I guess, what percent weight loss maintenance is clinically significant? I guess, what would be meaningful to patients? Then I have a follow-up. Thanks for that question. I think meaningful to patients, right now, within one year, people gain back 66% of what they've lost. That's what the data shows. In general, we want to say that if you maintain 50%, that clinically is significant. I think patients would want to see, even if you half that, if they're not gaining back 66%, if they're gaining back 30%, I think they will tolerate that. I think the data Harith showed earlier, I think patients would really gravitate towards even just that. Okay. That's very helpful. Thank you. You also mentioned that you have some patients interested already. I guess if you could just provide a bit more color, like how many patients are interested, what percentage of your total practice does that number represent? We just recently had these conversations, and this was something that I learned about earlier this year. I've been informally asking patients. I don't have hard data. I haven't kind of put this down, but virtually every patient I've brought this up to has been excited about it. I haven't had anyone say, "No, I wouldn't be interested in that." They're all intrigued by it. Of the patients that I have on GLP-1 that I've just gently talked to about is, "Hey, if we had something like this, what would you think?" Their eyes typically light up, and they're very interested, especially when you describe that it's a non-surgical procedure, and we're not changing any of their anatomy, and we're not burning any bridges. I think right now, the majority of the patients I see are getting GLP meds. I would say I'm probably seeing about 20% of my patients opt for surgery and 70%+ opt for GLP-1. It used to be that if I had 10 patients a day, it would be 70% surgery, 20%, 30% medication. I leave that extra percentage because some people just want me to do lifestyle stuff with them. That has completely flipped around. Now, the majority of patients want GLP-1, and virtually all of them are interested in something to lock in the weight that they've lost. The last thing I'll say is that a lot of patients also are okay with coming back every few years, every five, six years, to get a re-up. What you'll find is that patients, for example, when we first started doing GLP meds, I think it was Saxenda, it was a once-a-day injection, and nobody wanted it for weight loss. When it turned into a once-a-week injection, now people like it. When people know that they can have these procedures done at a longer interval, it makes it more and more appealing. Got it. That's super helpful. Thank you so much. Sure thing. Thank you, Angela. Our next question comes from Chase Knickerbocker at Craig-Hallum. Please go ahead, Chase. Good morning. Thanks for taking the questions. One for the company first and then a follow-up. Just trying to get a sense for how you see your early positioning with commercial payers, versus Medicare, where you have potential payment clarity through pass-through. Maybe just over those first five to eight quarters of launch where you see getting to break even, what do you expect your payer mix to be in that kind of break-even timeframe from a perspective of commercial versus fee-for-service and Medicare Advantage? Thanks, Chase. I'll take that one. This is Mike. Well, as we said, we're focusing on CMS because of all of the mechanisms and the tailwinds that we have, the GLP-1 bridge program, transitional pass-through. There's going to be a growing number of patients looking for an off-ramp 12 months from now. But with commercial payers, we plan to engage with them early. We've already started some of that work. We don't have a sense for payer mix quite yet because that's shifting and will shift pretty dramatically over the next year. But we are planning to focus first on CMS, but while in parallel, engaging with private payers. We plan to hire a prior auth and appeals third-party company to do all of those kind of the hand-to-hand combat. With new procedures, we'll have a Category III code in place, and so it is still part of our strategy, but we know that that's going to take a little bit longer as we build our CMS business. I'll just add with a couple of points. First is our assumption built into our modeling that most of these patients are going to come from CMS in our initial launch, and anything that comes from private payers will be upside. Secondly, payers are not a monolith. You've seen the five major players and their coverage policies. Our observation is that those who are self-insured employers or integrated delivery networks are tending to cover for GLP-1s and see higher costs. Conversations that we've had with them informally suggest they would be the earliest to adopt on the commercial side, and then we would grow from there over time with the registry. So, assume very small private contribution early on, but growing over time. Makes a lot of sense. Thanks. Maybe Dr. Ayoola, can you just give us your perspective of how you view the learning curve for the Revita procedure for bariatric surgeons, I think particularly those without large endoscopy practices today. Maybe just give us your thoughts there. That's a great question because bariatric surgeons aren't a monolith, and so you have so much variation. You have people that only do procedures. You have people like myself that are comprehensive. When I say a practice like mine is comprehensive, I do my own endoscopy and things like that. So for me, the learning curve, and for folks like me, I'm not the only one, obviously. For folks like me, the learning curve I don't expect to be too steep because we are familiar with endoscopy, and are comfortable doing things like deploying stents under fluoro and putting endovac in and things like that. It's hard to know how many of folks, bariatric surgeons like myself versus others, but certainly people, you can have an idea. If I were to guess, I'd say 30%-ish, 30%, 40%. Those are people that attend meetings and attend endoscopy courses and things of that sort. If you have that experience already, then you will be fine. The other thing I will point out is that a lot of times, bariatric surgeons are very motivated to learn new stuff because, for example, when the lap band was the rage, everybody went and figured it out and learned it and things like that. I think if you see Revita being adopted, you are going to find all these surgeons very motivated to learn that. It is a shorter course for folks like me that have been doing these procedures. I would expect to be up and running within 5- 10 cases very easily. Then you see folks that are not as experienced needing 20- 25 cases to get reasonably technically efficient. Very helpful. Thank you. Thank you, Chase. Our next question comes from Rohit Bhasin at Morgan Stanley. Please go ahead, Rohit. Hi, thanks for taking our questions. Can you just talk about your thoughts on durability of the procedure? What do you think is clinically meaningful? Thanks. Dr. Ayoola, that may be a question for you, but I will go ahead and take it. Our market research suggests that something that lasts more than a year begins to become interesting to patients. Less than a year would not be interesting, but thankfully the data that we have suggests at least one year of durability so far. I think at somewhere between 18 and 24 months might be a sweet spot from a modeling standpoint, to be fair. Beyond that is going to be attractive to patients, may be able to enable higher pricing as we have talked about, but there are so many patients who have told us. The ratio of patients who have told us that they would repeat the procedure at 18- 24 months suggests to us that even if that were the duration, then we would have excellent uptake. However, we have seen 24 months of durability in our type 2 diabetes work, and we will see 24 months of durability from weight maintenance by next year. We are quite optimistic about two-year durability from where we sit today. Thank you. I guess for Dr. Ayoola, in your practice, what are patients' perspectives on a maintenance strategy where they are staying on a GLP-1 on a lower dose or a lower frequency, versus a procedure such as Revita? Thanks. A lower frequency is certainly what most patients opt for. They can tolerate that low frequency for a while. I think that repeatedly you just find patients stop following up, because in the back of our minds, for whatever reason, people just really feel like once the number on the scale hits their goal, they should not have to do anything anymore. The concept of obesity being a chronic disease still just has not taken. People get it with diabetes or high blood pressure, but with obesity, the people really just feel like if they just get down to that number, they will be able to maintain it without having to do anything or anything additional. And that's what I like about Revita is that, okay fine, if you want something that kind of gives you a break from having to worry about this stuff so much, then this is what it is. And that's where mentally people just are. Even when you're talking about microdosing or extending the frequency and things like that, they like it, they prefer it, because the less they have to worry about it, the better. But what better than to do a short endoscopic procedure that then gives you a year, two-year, three-year holiday from having to worry about this stuff? And that's why I think it's so attractive. Thank you. Thank you, Rohit. Our next question comes from Jason Gerberry at Bank of America. Please go ahead, Jason. Hey, thanks for taking my questions. Maybe for Dr. Ayoola. You mentioned, I think, for your patients on GLP-1, I think you indicated like about 100% are looking for some sort of off-ramp. I was wondering if you could drill down a little bit more into that, like what proportion you think are amenable to something like Revita. Do you think that an off-ramp may entail Revita and perhaps a lower dose of an anti-obesity medication, or do you think that it's kind of cold turkey on the medicine? Just kind of curious how you're thinking about that dynamic. Then, just trying to get your sense of like patient's appetite once they do discontinue GLP-1 to reengage either with like a lifestyle modification, a pharmacotherapy alternative. Just trying to think in the context of what other alternative mechanisms like amylin are available that may have a gentler side effect, and how you see the interplay of that versus like a Revita-like option. Thanks. Thank you. You touched on a few things and one of the slides I really like, when I saw Harith's presentation, was the one looking at the different steps. This is step 1, prove it. It is focused on just maintenance of weight loss after GLP-1. What you are talking about is more the step 2s and the step 3s. What does it look like as an adjunct to oral injectables, procedures, other things? What you are expecting to see is additional weight loss. The last thing is frontline, where you just use it straight up without anything else. It is just your primary treatment. I think these are all very appropriate things to think about, and I think things will move very quickly, honestly, in that direction. The reason I say that is that my approach and the approach of most people that do this comprehensively is nothing is bad. Everything is just another tool, another option. What you will find is that patients are very different. Some people will come in and they will be like, "I do not even want to take the GLP, I just do not want surgery, but give me something." Revita, as a frontline, can do that. There are other people that say they want to lose X amount of weight, and you know the GLP is not likely to do that. Those are the people where it is Revita plus GLP-1, and they are happy to stay on both. As I said, decreasing the frequency of the GLP as they go further along for cost reasons and just lifestyle and things of that sort. All of these things I think are very relevant, and you are going to have a mismatch of patient population that wants one thing versus the other. It is very difficult to say ahead of time what those things will break down as, but you know for sure you are going to have that. There are people that come in, and they are very, very serious about the lifestyle component, and there are people that really just are honest with themselves, and they are like, "Yeah, I am not going to do all these other things that I know I should do. I just need something to help me with that." If I missed any specific question you had, please repeat it, and I will address that specifically, but I am just giving you the broad idea of the gestalt I get from talking to patients day in, day out. No, that's really helpful. I appreciate the feedback. Thank you. Thank you, Jason. Our next question comes from Jeffrey Cohen at Ladenburg. Please go ahead, Jeff. Hey, thanks for taking our questions. Two in particular, I guess, maybe firstly for Mike, if you could talk a little bit about the fixed equipment and generator as far as placing, leasing, or selling at specific facilities and how you think that plays out. Yeah. Thanks for the question, Jeff. Yeah, we're thinking about pricing the Revita as a system, so doing a placement agreement for the console, which we've done in previous companies, and that's a workable solution, and having the cost rely on the single-use catheter. So right now, that's our strategy is to start doing the contracting after we get FDA approval or clearance, and start having those conversations. But early on, and based on my previous experience, that's a model that works pretty well, and takes advantages of all the mechanisms that we talked about. Got it. As follow-up, I guess a question for Dr. Ayoola as well as Mike, yourself, and Harith maybe. Could you talk about the specialties out there? I know we heard about bariatric surgery, and maybe talk about GIs and perhaps speculate as far as which segment will be driving the procedure more in a commercial setting out there. Thank you. So maybe Dr. Ayoola, you could start just by talking about how your field has evolved over the past several years and then I can talk about GIs and the role they will play. Thank you. So obviously I am a bariatric surgeon and will come off incredibly biased, guilty as charged. But I do think that bariatric surgeons like myself that are comprehensive are a natural fit for this. I would not say every bariatric surgeon because there are those that simply want to operate. They do not prescribe meds. They do not do anything else. They just want to operate and do procedures. But for those that take a comprehensive approach, I think that is a perfect fit. That is someone that can walk the patient through every conversation, every tool, and can perform all of these things and prescribe the medications and so on. I think that if you have someone that is an interventional endoscopist, again, not all GIs will be able to do this or want to do this, but if you have interventional endoscopists that could work as well. The difference though is that they will be focused more on the procedure than they are on the overall follow-up and things like that. So that is the concern there. I would wager interventional radiologists could probably do this, but again, the question is who has the best overall approach to it, and I think that would be bariatric surgeons that run a comprehensive program. And you have seen that folks doing lap band in the past, sleeve gastrectomy in the past, those are the operations on the lower invasiveness level. And so something like this is relatively low on how invasive it is, and so that is something that will be appealing, I think, to most bariatric surgeons. And what we observe about bariatric surgeons is that they have literally everything in place, ready to go so long as they want to incorporate Revita endoscopically into their practice and are doing endoscopies themselves. Dr. Ayoola said about 30% of the 2,000- 3,000 surgeons in the U.S. fit that bill. We would agree roughly with those numbers. When we talk about 100- 200 centers over the first couple of years, I would tell you that those are already surgeons like Dr. Ayoola who have all of the capabilities already in place and the endoscopy skills already. They just need to be trained on Revita specifically. So we feel very good about that. One thing about bariatric surgeons also is that those who have migrated to this comprehensive view are prescribing diet and lifestyle and prescribing medications. Many of them are ABOM certified as well as surgeons and so are staying up to date on amylin and other drugs that come, but then also can offer interventions as part of a comprehensive set of offering for patients where we think Revita fits. In GI, I would tell you that the endoscopic skills are, let's say, already right there. There is a smaller set of gastroenterologists who have already built comprehensive practices like Dr. Ayoola has in bariatric surgery around endoscopic offerings. That's why we focus on a couple 100- 300 in our numbers rather than the 15,000 endoscopists in the U.S. However you slice it, the targeted efficient commercial model with high volume centers could really enable substantial growth for the early launch and the foreseeable future thereafter. We are very excited about how this field could grow. We see convergent evolution between GIs and surgeons towards metabolic interventions, and that convergent evolution is why we sort of view them as one potential customer. Every one of these metabolic interventionalists has all of the same features, which is a desire to do this endoscopic procedure, all of the wraparound services necessary, and the patients in their panel already who are actively seeking an alternative to just chronic medications. That's what we think would be the lowest hanging fruit for us. Thanks. That's helpful. Thank you, Jeffrey. Our final question comes from Joe Pantginis at H.C. Wainwright. Please go ahead, Joe. Hey, everybody. Thanks for all the details today. One question for Dr. Ayoola and one for the company. Dr. Ayoola, you really provided a lot of details answering my questions, and I believe a lot of others. I wanted to take one of your comments and flip it on its head with regard to playing devil's advocate. That's, patients don't necessarily want to go under surgery and might be more amenable to endoscopy. Do you have, or what level do you see of patients that don't even want to have anything interventional like that? Oh, 100%. You have 40% of the population dealing with obesity. We surgically treat 0.3%. Even with GLP, you're still only plateauing the rate of growth. You're not even pushing that the other way. I think this is actually opportunity rather than every problem is an opportunity. One of the questions I was asked when we were discussing this was, "Do you think you're going to run out of patients?" I almost fell out of my chair laughing because the problem is giving people options and catching more and more people to treat with options because the problem is so prevalent, and as much as we're fighting, we haven't pushed back enough. I agree with you that there are patients that just don't want anything, but they also don't want to continue suffering with obesity. Even if they don't care, the healthcare costs are astronomical. The downstream effects of obesity, it can't be ignored. At some point someone needs to crack the code, and I just think that having this product is part of that cracking the code. No, absolutely. That is very helpful. Thank you. For the company, this is obviously very forward-looking, but I am going to ask it anyway, and hopefully you can take a first shot. What kind of label do you anticipate, especially when you are looking at the current data sets of having an optimized population, and seeing better success rates in the greater than 14 cm and greater run-in weight loss? Well, anticipating a label is sort of like predicting what the FDA is going to do. Yeah. I would rather not answer the question that way, but I think everyone would want to be able to have us identify patients and a procedure that are most likely to deliver benefit for patients, and the highest quality benefit that you can deliver. What we saw from our pilot studies is that more ablation length corresponds to greater efficacy. We are convinced that physicians can be trained on that greater ablation length once that is established. The appropriate place for that could be in an instructions for use or part of the data set, which is what we have built into our trial. I think that if more ablation is better, we believe that should be very clearly stated as part of physician training and the certification processes. Secondly, with respect to more run and weight loss, again, what we observed in the midpoint cohort, for those who are listening, is that the sham arm regains weight far more rapidly if there is more weight lost on the GLP-1 to begin with. That is consistent with what you see in the trials from the pharmaceutical companies. It is consistent with what you observe in real world. So translated, the patients who are at greatest risk of weight and metabolic rebound are those with the greatest responses to these agents. I believe that physicians and patients should be appropriately informed of that, assuming the pivotal trial continues to manifest what we observed in the pilot in order to be able to make an informed decision. As Dr. Ayoola said, there are so many people who have lost substantial weight, plateaued, looking for an off-ramp. There are so many new drugs that are coming that are going to be even more potent than those that already exist. For me, it really boils down to optimizing the benefit-risk calculus, and the risk side of the equation we've not really talked about. Luckily, because it looks so promising, we have not observed an adverse effect level, even with longer lengths of ablation, which suggests to us that there may be more room to probe on ablation length even than what we are showing here. It also suggests to us that there is really no downside that we have observed with longer lengths of ablation. I hope that answers your question without talking about what the label will actually say, but more about what we think the market needs in order for people to really embrace this. Certainly does, Harith. Thanks for all the details and great call. Brian? Thank you for your questions, Joe, and thank you to our speakers, analysts, and audience for joining us today. This concludes our event. You may now disconnect.