To present the icon at the bottom of your screen. With us, we have the CEO, David Hochman, and the CFO, Andrew Taylor. David, it's all yours. Thanks, Jim, Andrew will join me for Q&A. I'll jump right into it. Okay, there we go. We think we have a phenomenal opportunity at Orchestra BioMed that's really been purpose-built to leverage partnerships to advance high-impact medical device therapies, and allow us to build a business through those partnerships that we think can be exceptionally profitable in the future. This business is built on really three pillars, and we'll talk about them in detail in this presentation. Two now pivotal trial stage flagship technologies that address significant unmet needs in two of the most established cardiovascular device markets. A business model built on partnering that allows us to be much more capital efficient for the long term, because we'll make money off of substantial royalty-based revenue shares with our partners. Our partners will fund and drive commercialization through large established channels. Most importantly, we have a big year ahead as we work towards our first major pivotal trial readout for the BACKBEAT trial. We think that we have a significant number of milestones coming up over the course of the next three to 12 months that I'll talk about in detail for that program. We're actively now enrolling our VIRTUE trial that I'll talk about as well, which we hope to finish enrollment in 2027. Importantly, the company is well-funded to achieve these milestones with cash in place through the late part of 2027. The two flagship technologies are really what's core to our opportunity, and I'll go into them in more detail. AVIM therapy is our most advanced program. This is a unique cardiac pacemaker programming-based treatment that addresses significant unmet needs associated with hypertension and hypertensive heart disease in older comorbid patients. As I said, the pivotal trial is nearing completion. We have two Breakthrough Device designations. This addresses a very large global market opportunity, and we have the best partner we think we could have for a pacemaker-based therapy in Medtronic, which really was founded around the pacemaker and is the global market leader in cardiac pacing, controlling half of that global market. We have a significant revenue-sharing arrangement that I'll talk about in more detail. Our second program, VIRTUE-SAB, or Sirolimus AngioInfusion Balloon, is a highly differentiated drug delivery system for the treatment of artery disease. We just started our pivotal trial the late part of last year, have three Breakthrough Device designations, also address a multi-billion dollar market, and have a rights agreement with Terumo, the largest Japanese headquartered global medical device company. They have a right of first refusal for the coronary applications of this product. I'll talk more about that as well. I wanted to highlight our team. We're a relatively small company at around 90 employees with an outstanding, highly experienced leadership team. We've brought together an exceptional team that is great at doing what we need to be great at, which is creating intellectual property and driving it to the market. As CEO, I'm proud to lead a team that has eight members of our senior team that have also been CEOs of development stage medical device companies. We have a phenomenal independent set of board members that span expertise and experience in the biotech as well as the med tech arena. I'm going to walk through the AVIM program, which once again is critical because we have key milestones coming up. This is a first of its kind proprietary cardiac pacing therapy for hypertension and hypertensive heart disease. As you'll see, this is a therapy that immediately, substantially, and persistently lowers blood pressure and is delivered through a well-established, actually one of the most well-established medical devices, a pacemaker. Our pivotal trial is supported by prior outstanding clinical and mechanistic results from our other studies, which I'll summarize. I want to first talk about the market that we see, a significant large addressable market that we see, and we think it's very clearly defined. Importantly, we have, we think, a uniquely attractive initial market opportunity to treat hypertension in patients that already are indicated for pacemakers, so patients that already need the device implant. Every year around the world, approaching 1.3 million patients get pacemakers. We think about a million of those patients are addressable because they have hypertension. It's the number one comorbidity in that population. At least 70%-80% of patients that need a pacemaker have hypertension. Importantly, the $2 billion-plus opportunity here is based on established reimbursement, offering our partner a differentiated high-impact proprietary therapy to layer on top of their existing business to recapture reimbursement dollars that have been commoditized out of the current device pricing. This initial market leverages the same patients, the same implant, being done by the same physicians in the same reimbursement structure with commercial upside. There could be upside to that reimbursement. Importantly, when we think about blood pressure reduction in older, higher-risk patients, and just so you know, average age for a pacemaker patient is 74 years old, we're really talking about addressing the key risk factor for death that drives heart attack, stroke, and progression to heart failure. We're thinking about benefiting patients that we can prevent those events, but we also can potentially prevent and treat patients that have heart failure, particularly HFpEF, with continued elevated blood pressure. That opens up a very significant expansion opportunity into the treatment of what is called hypertensive heart disease, high blood pressure driving all of these other major events and risks. While there's 1.2 billion patients around the world that have hypertension, we think there's a very targeted population, a little less than four million patients annually. Less than one-third of 1% of the global population that are older, comorbid, where we now can take this familiar implant, very well-established, and ultimately make it indicated and get it covered for treating hypertensive heart disease, leveraging AVIM therapy. A big expansion opportunity. Key to our opportunity, once again, is our partnership with Medtronic. I want to just talk about what we and Medtronic both bring to the table and how we are positioned to make money alongside Medtronic on the success of this therapy. First off, our team developed AVIM therapy from concept stage. We own all the related intellectual property. We think it's a dominant position. We have 120 issued global patents just related to hypertension, more related to heart failure. We've conducted two prior multi-center perspective studies before we partnered with Medtronic, and I'll talk about particularly the data from MODERATO II, which was our think of it as our phase II pilot for the now BACKBEAT global pivotal study that we are sponsoring. We're running the study, but we have huge help from Medtronic. Medtronic, many of you will know, is the market leader in cardiac pacing therapy. They are a $34 billion company, but a large business of theirs is pacing over $2 billion in annual revenue. Once again, they are the dominant player controlling half the market, more than half the market in the U.S. Because of their market size, we've entered into an exclusive global commercial rights deal, licensing deal for the initial market, the hypertension in the pacemaker population. This envisions progressing through both transvenous and eventually leadless pacemakers. While Orchestra's running the pivotal study, ultimately Medtronic is responsible to take over to file for approval, to market, sell, support the device, and manufacture the device. This is where the partnering model gives us tremendous leverage. While they have exclusive rights for the pacemaker opportunity, Medtronic has a right of first negotiation. We think that's an interesting, exciting opportunity as we approach the BACKBEAT pivotal data to expand the partnership. Already, Medtronic has invested as well as made a strategic capital payment of just under $82 million in Orchestra BioMed. They own 16% of our outstanding equity. Our deal is really based on royalties. On the bottom left, you can see that we are positioned to make between $500 and $1,600 per AVIM-enabled device. Once again, assuming the limits of existing reimbursement, we have upside to the extent that Medtronic will choose to pursue add-on reimbursement opportunities, particularly in the U.S., that could be enabled by our Breakthrough Device designations. The $500 represents the per-device minimum payment that we would receive outside the U.S., but excluding China and Japan, which are large and key markets. Our U.S., China, and Japan minimum payment is within this range, but materially higher than the $500. We participate alongside Medtronic in the upside of higher potential pricing. Once again, this is limited by existing reimbursement. On the upside in places like the U.S., we could see potential per-device payments of $1,600. Just to put that in perspective, we picked the low midpoint of $1,000 as a global average. We can look at that market opportunity of up to a million patients, of which half are already Medtronic device patients, and see that this could be quite a substantial royalty stream and also a significant growth in revenue and profitability driver for Medtronic. This is all based on having a proprietary therapy that really we know how it works, why it works, and we'll show you the data, how that's translating. This immediate, substantial, and sustained effect is once again built on top of a device that's been around for over six decades. It's delivered through the same dual-chamber pacemaker. Particularly the pacemaker patients don't need another procedure. It's compatible with both the standard right ventricular lead positions, but there's a big paradigm shift happening with conduction system pacing that is very complementary to our therapy. Like any pacemaker-delivered therapy, it's activated by the programmer. It's programmable, adjustable. It's not dependent on patient adherence. It's running in the background, and it can be turned on or off as needed. Atrioventricular interval modulation really describes exactly the mechanism. We lower blood pressure by reducing the time window between the atrial and ventricular contraction. That directly reduces cardiac preload and can drop blood pressure significantly immediately. That drop is going to essentially elicit an autonomic reaction from the body, and we modulate and manage that reaction by interspersing intermittent longer AV intervals, essentially allowing blood pressure to rise so you don't get an autonomic response, sympathetic response, and we don't see a change in peripheral resistance. Fortunately, for those you know, preload, afterload, peripheral resistance, and sympathetic tone, these are what we prescribe drugs to treat. We're doing all the same things, but through a pacing mechanism that is complementary to drug therapy. Our pilot study, our double-blind randomized pilot study, was called MODERATO II, and I'll show you the data. This is actually new data we shared on the immediate effect. This was a randomized, prospective, multi-center, double-blind study before our partnership with Medtronic, looking at patients that needed a pacemaker but also had high blood pressure despite medication. What we do with this therapy is we really actually set it up and make sure it is working before we randomize patients. To make sure it's working, we're looking to generate at least a five-millimeter reduction in blood pressure. In MODERATO II, we were 97% successful, this is near universally successful to get that response in patients. Importantly, we do much better than five millimeters. We generate a 13.2 mm average result acutely in this study. Importantly, that 13.2 mm result translates across all endpoints out to two years into a similar robust double-digit reduction in systolic blood pressure. Our one-day ambulatory, and I'll talk about ambulatory blood pressure monitoring in a minute, but that's really the gold standard result, is here, a very significant effect that's sustained out to six months. The six-month, the one-day results, both office and ambulatory, were highly statistically significant versus control. I don't have the control data on this slide. Safety looked better. Once again, the long-term results in office blood pressure were outstanding. Importantly, there's no increase in average number of medications during this full two-year period. We have follow-up data on a cohort of patients actually out to four years that I don't have in this presentation. You can see what we mean by ambulatory blood pressure. This is really the trace of blood pressure results over a full 24-hour period. The gray is the average result in our patients before they were randomized and activated. You can see that 11-millimeter translates into really a change in the whole blood pressure profile over the course of the day, this is where you can really have a huge impact on preventing those events and progression to heart failure. Our data, just to showcase a few things, is really impressive when we think about the older high-risk patients that we're treating. Those patients have stiffer blood vessels, stiffer ventricles, almost 90% of our patients have what's called isolated systolic hypertension. We really target that and allows us to reduce pulse pressure. A lot of these patients have diastolic dysfunction of the ventricle, and we saw that AVIM therapy drove improvements in diastolic dysfunction as well as drove positive reverse remodeling of the heart, essentially made the heart smaller and more efficient, a key sign of our ability to hopefully slow or prevent the progression of heart failure. Our major endeavor, as I mentioned at the beginning of the presentation, is the BACKBEAT study, the global pivotal trial for this therapy that we're running in conjunction and partnership with Medtronic. This is going to enroll up to 316 patients, and we're nearing completion of enrollment, targeting the end of next quarter. Here, we're not implanting devices. We're downloading our therapy into patients that have shown uncontrolled hypertension despite one, two, or three medications that have received Medtronic's top-of-the-line dual-chamber pacemakers. Once again, the qualifying patients are getting set up with AVIM therapy. We're actually able, in this case, to download it to those devices, and we're seeing that they get that response that I talked about earlier prior to randomization. We really have all responders in the trial, and that's the vast majority of patients. Simply the device is turned off. The patients are on a blinded basis randomized, and AVIM therapy is turned on, blinded to both the patient and physician. The primary endpoints are being assessed at three months, which is really the most typical endpoint for blood pressure drug studies. We're looking to be superior by that measure I showed, the 24-hour ambulatory blood pressure, and looking to show freedom from unanticipated serious adverse device events. Given the long history of pacemakers, there's a very clear understanding of the type of events patients have. These are older patients that have events. We're making sure that AVIM doesn't generate unanticipated events. We have high confidence in both endpoints and are excited about the data coming next year. The study is blinding through 12 months, so we'll also have additional data that could be important to therapy adoption, looking at both efficacy and safety on a blinded basis through 12 months. Truly a global study where we're getting clinical experience across sites in the U.S., Europe, as well as China. Most importantly, the milestones are significant milestones that are coming up over the course of the next year. The next key one, we think, is the completion of enrollment, which we're targeting for the end of next quarter. By the end of the year, we're targeting completion of the primary endpoint visits. We'll then, with Medtronic and our statisticians, analyze the data with the aim really to focus on sharing this data as it deserves to be shared as a late breaker at a major cardiovascular conference. We'll look to get the data published, and at the same time, Medtronic will take over responsibility. They plan to file for FDA approval and global approvals with an ideal timeline of commercialization in 2028 in the U.S. and globally over the course of that year into the next year. Having the partnership with Medtronic allows us to really think about this therapy moving quickly to the market, to patients broadly, and hopefully towards a course to potentially become a standard of care for better blood pressure management in the pacemaker population, with the growth into the expanded population. I want to shift gears to quickly give an outline of what we think is another really exciting flagship program, the Virtue SAB program. This is a first-of-its-kind drug delivery system that features a proprietary extended-release SirolimusEFR formulation, same drug, but our own formulation for extended release, delivered as a large liquid dose through a balloon, a unique technology. We believe, and I will show you the data, our data is best in class, and it's based on things that are known and well established, but that we innovated to make possible for broad clinical and commercial use. This is a therapy that layers on top of a large established global market. Coronary and peripheral artery disease treatment is about a $10 billion global market, but the paradigm for that market is changing from drug-eluting stents in the heart to drug-coated balloons. A large portion of the market outside the U.S. is already being treated with drug-coated balloons. Boston Scientific got their AGENT paclitaxel balloon approved as the first coronary drug-coated balloon in the U.S. and did a great job of establishing very attractive enhanced reimbursement that's enabling average selling prices in excess of $5,000 per balloon. Currently, Boston's the only company on the market. We think there's a very compelling opportunity for a novel, differentiated, and better sirolimus-based solution. What do we know about sirolimus? We know sirolimus is the drug of choice for drug-eluting stents, and its safety and efficacy superiority has been proven versus paclitaxel, which is the drug that Boston Scientific and others have on their drug-coated balloons. That's proven through as many as 26 randomized controlled trials. The challenge, though, with sirolimus is a stent is a great platform for delivering a drug that needs to be delivered at a minimum dose concentration and available for at least 30 days. We move away from a permanent implant, like a stent, to a drug-coated balloon. The shift went back to paclitaxel just because it's easier to coat, easier to get it to have its cytotoxic effects in a short window of time. The inferior drug has essentially become the most common choice, and that coated balloon concept has real challenges that we see we can overcome: limited dosing on the surface, the risk of particulate, the risk of drug loss in transit. We built a proprietary formulation of sirolimus to enable focal, localized, extended release, and we deliver a large dose of that drug through the balloon. We've really demonstrated what makes this a differentiated, potentially optimal solution for treatment of coronary artery disease. We know how much drug needs to be there. The one nanogram per milligram therapeutic dose concentration is well established from stents. You can see in our large number porcine coronary artery published study that Virtue and SirolimusEFR levels are nearly 10-fold what a stent achieves through the 30-day period that I referenced. What doesn't go where we want it to go is below the level of quantification in distal myocardial tissue and end organs by around day four. We have demonstrated the pharmacokinetics and actually optimal pharmacokinetics, and we do it with a device that we think offers advantages for the physician. There's no coating, no worry of drug loss in transit, no need to rush, no worry about particulate. They really control drug delivery because they're inflating the balloon with the drug formulation at the back of the catheter. We think about this in terms of data. That's really where we see the biggest opportunity for Virtue. Here's the data from Boston Scientific's pivotal trial in the U.S. Their AGENT paclitaxel balloon is in green. The gray bars are their comparator arm, which is a plain balloon with no drug. The endpoint here is target lesion failure, and they were treating what's called coronary in-stent restenosis. Here's the data from one layer of stent, patient had a prior stent, and now that stent site needed to be retreated. With target lesion failure, you want a low event rate. Essentially, it's measuring, did you have an adverse event or need to retreat at different time points? The primary endpoint was one year. You can see that the AGENT balloon was superior to a plain balloon in these patients with a rate of 13.5%. The relative increase is almost 100% over the next two years, 50% a year. We think there's opportunity for improvement on this type of data, and this data appears to be consistent with other drug-coated balloons. With Virtue SAB, we see a different data signal from our multi-center pilot study in the same type of indicated patients. With a very low 2.8% target lesion failure rate at one year, a small increase at two years to 5.6%, and no increase in target lesion failure from two to three years. Essentially, a better outcome that seems to be more durable, and it makes sense. We're delivering a drug we know works, but we're delivering more of it in an optimal fashion without leaving metal behind. With that data, we're confident that the best way to get approval, but also to differentiate the product, is to run the Virtue trial where we're randomizing head-to-head versus AGENT up to 740 patients in-stent restenosis. This study, we think, is high probability of success with a non-inferiority endpoint. Really, we're looking to this study to differentiate Virtue with numerical or ideally statistically superior differentiation versus the market leader. This study, as I noted earlier, began in late 2025 and is targeted for completion enrollment next year in 2027. As we mentioned, we have a strategic relationship with Terumo. This is a simpler right of first refusal agreement, we are free to talk to other parties. Terumo has a 30-day window if there's a deal we want to do to respond and look to match another party. In total, Terumo paid and invested $65 million to support and secure this right of first refusal. Once again, Orchestra BioMed is built on a very high-impact pipeline of two platform flagship therapies with clear lead indications, expansion opportunities, multiple Breakthrough Device designations, and pivotal trials that are actively enrolling with the BACKBEAT AVIM pivotal trial slated for data approximately a year from now. Hopefully, it's been clear that we have a really exciting opportunity built around those technologies and the needs in those markets, a business model that really allows us to think about move to profitability faster since our focus is spending our money on the development work and leveraging partners for commercialization, and a big year ahead with our first major data readout with the funding in place to get there. Hopefully, we have a few minutes, Jim, for some questions. Great. First couple from me. Two very exciting opportunities. With the BACKBEAT or the blood pressure device, you mentioned there's a market that Medtronic has the rights to, and there's a market that the market has the right of first refusal to. Can you just compare those two markets, explain the difference? Sure. I'll go back to make sure the slide that addresses that is up while I speak. The market for which Medtronic has exclusive rights is patients that have an existing indication and a reason to get a pacemaker that presumably also have hypertension, and that's up to 80% of those patients. This is the market that Medtronic created, the market that they dominate. Really, half of the market is controlled by Medtronic. In the U.S., their market share, we would estimate, is close to 55%. Here you're taking the market leader and giving them the technology to create now a new top-of-the-line device that has the ability to run AVIM as well as provide standard pacing therapy. They have exclusive rights. They leverage our and they're protected by our patents. Obviously, we're running a full pivotal clinical and regulatory pathway for approval. Right now, there's no competitors that are in the clinic at all with a competitive therapy. That market's quite attractive and, once again, very substantial in terms of what it can do in terms of Medtronic's impact, our royalties. If our therapy works as the way we expect it in a patient indicated for a pacemaker, part of the Breakthrough Device designation, one of the Breakthrough Device designations we got from FDA covers, actually, it's up to eight million prevalent patients in the U.S. that don't need a pacemaker that have a lot of the same demographics and health issues. They have blood pressure disease, other comorbidities, where you're really worried about how do we effectively control blood pressure so we minimize risk of heart attack, stroke, and heart failure? The device for that patient population would be the same. TriVinc doesn't need a new device, simply need to get regulatory indication. Once again, you can also map to the same reimbursement, but you would need coverage. There's a couple obstacles to go over to get through to get there, but they're pretty clear, the BACKBEAT trial is going to lay the foundation for that opportunity. Medtronic is obviously interested with a right of first negotiation. There is obviously alignment around that expanded business partnership that we and Medtronic would look to achieve over the course of, let's say, the next year or so as they work towards approval for the initial market. That secondary market looks like it's a much bigger market. It is. It could be four times, we think we've been conservative in estimating it. Once again, you think about the significance of pacing to Medtronic today, approaching $2.5 billion of revenue, very significant cash contribution, growing their existing business, very attractive, doing more benefit for the same patients, very attractive. The opportunity to potentially double or more that implant business through an indication to an expansion market could be a game changer. We're excited about the initial market, we see a clear path ahead, but very excited about the potential of AV-IM to benefit. Once again, Jim, this is a slice of a slice of the one billion people with hypertension. We know it's an implant. We're targeting the older, sicker, higher-risk patients, we think that is something that the data we're going to generate is going to open up that opportunity in the next few years. Medtronic obviously is pretty confident about the device. I saw they gave you some additional funds last year. Then you also got some funds from Ligand Pharmaceuticals, which- Ligand, yeah. We've been very creative in financing the business and aligning ourselves with the right partners. Ligand is a fast-growing, now $6 billion market cap royalty aggregator, mainly focused in the pharmaceutical space. We think their largest ever foray into the medical device arena. Ligand put $40 million into Orchestra last year, $5 million of equity, $35 million to essentially purchase a slice of our royalties in the future. Great aligned strategic capital partner that's betting on the long-term future of both programs. Between the funds you received from both, is that sufficient to get you through the patient enrollment? We raised actually about $150 million in capital last year, that'll get us through enrollment, which is coming up quickly. Actually, our guidance is that we're funded into late 2027. Beyond the data from the BACKBEAT trial and hopefully through the enrollment of the Virtue trial. We're well-funded, in our opinion, undervalued, and in a position to create a lot of value for shareholders with the milestones coming up in the year ahead. Right. We're running out of time. Still a ton of questions. For Virtue, just a quick one. The trial you're doing now is coronary, but do you foresee a peripheral application at some point? We do. We definitely believe that our drug formulation can have significant benefit both in the upper leg, the lower leg. We hope to provide some updates. We think we have also a unique approach in which to deliver the technology that would offer advantages in the periphery, potentially advantages in the coronaries as well. We plan to provide some updates later this year, not just on the current trial, but also on the pipeline and how we're applying our technology to optimize our opportunities in coronary and peripheral and beyond. Okay. Well, we are at time, unfortunately. It sounds like both opportunities are well on their way. It seems like a very exciting time to be there. Appreciate the update. We're working hard. We love sharing the story, and we're excited about what we're going to deliver in the near future. Thanks again for having us. Take care, Jim. Thank you. Thank you, everyone, for attending.