Picard Medical, Inc.

Good afternoon. Welcome to Picard Medical's first annual business update, featuring key opinion leaders and a patient testimonial. Before we begin, I'd like to remind you that management will be making projections and forward-looking statements on the call today regarding future events. Any statements that are not historical facts are forward-looking statements. These statements are made pursuant to and within the meaning of the safe harbor provision of the Private Securities Litigation Reform Act of 1995. We encourage you to review Picard Medical's SEC filings, which identify risks and uncertainties that may cause future actual results or events to differ materially. These filings can be found on the company's website within the investor relations section, as well as the SEC's website at www.sec.gov. Please note that the forward-looking statements made during today's call speak only to the date they were made, and Picard Medical undertakes no obligation to update them. Also, please see this slide with additional disclaimers related to the content within today's talk. And note that a question and answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the Q&A text box at the bottom of this webcast player or by emailing your questions to questions at LifeSiteAdvisors.com. As a reminder, this call is being recorded and a replay will be made available on the Picard website following the conclusion of the event. And with that, I'd like to now turn the call over to Patrick Schneckelsberg, Chief Executive Officer of Picard Medical. Patrick.

Thank you, Dori. Really appreciate the intro. If we can go to the next slide. Thank you. At Picard Medical, our mission is to pioneer the future of heart replacement. We are pursuing that mission in two ways. First, through the commercialization of the Syncardia total artificial heart, which today remains the only total artificial heart approved by both the FDA and Health Canada. Second, through the development of next generation artificial heart technologies designed to expand the role of artificial heart therapy and potentially serve as an alternative to heart transplantation. So our strategy is to build on established clinical platform while advancing technologies that can expand access to heart replacement therapy. Next slide. Today's program is designed to provide several perspectives on artificial heart therapy. I will begin with a strategic overview of the company and market opportunity. Our chief operating officer, Matt Schuster, will then review our technology platform, development pipeline, and operational initiatives. Our chief financial officer, Bernard Skaggs, will review the company's financial results. We will then hear from Dr. Amy Fiedler, who will provide the clinical perspective on the use of total artificial heart therapy at UCSF, one of our centers of excellence. We're also honored to have Marcella, a former Syncardia patient, joining us today. And finally, Zane Calpe from Honor Health in Phoenix will discuss the future of total artificial heart and auto-mechanical circulatory support technologies. Next slide, please. So before I continue, I would like to briefly introduce Dr. Fiedler. Dr. Fiedler is an associate professor of surgery and surgical director of heart transplantation and mechanical circulatory support at UCSF. She leads one of the leading advanced heart failure programs in the United States and has extensive therapy with heart transplantation and mechanical circulatory support. Later in the program, Dr. Feeler will share her perspective on patient selection, implantation experience, and on the clinical impact of total artificial heart therapy. Next slide, please. We're also pleased to have Dr. Calpe joining us here today. Dr. Calpe is Chief Medical Artificial Intelligence Officer and Network Director of the Artificial Heart Program at Honor Health in Phoenix. He's a cardiothoracic surgeon specializing in advanced heart failure and mechanical circulatory support. Dr. Calpe will later discuss how artificial heart technologies may evolve over the coming decade. Next slide, please. We're also honored to have a former Syncardia patient joining us today. Marcella was diagnosed with postpartum cardiomyopathy and received the Syncardia total artificial heart as a bridge to transplant. She was supported on the device for approximately nine months before receiving a successful heart transplant. Marcella's story highlights the real world impact artificial heart technology can have in keeping patients alive while they await the donor heart. Next slide. Advanced heart failure represents a major medical need here in the United States and also globally. Approximately 6.8 million people in the United States live with heart failure and more than 50 million globally. Within that population, roughly 300,000 patients in the United States suffer from advanced heart failure. However, while there are only 7,000 patients on the waiting list for heart transplant, only about 4,000 transplants are performed annually in the United States due to limited supply of donor hearts. Artificial heart therapy exists to address the structural gap between the number of patients who require heart replacement and the number of donor hearts available. Syncardia is the only FDA and Health Canada approved total artificial heart with more than 2,100 implants worldwide. Next slide, please. Most mechanical circulatory support technologies treat only one side of the heart. Left ventricular assist devices or LVAD systems support the left ventricle, while ECMO provides temporary circulatory support. The Syncardia Total Artificial Heart replaces both ventricles and all four heart valves and provides complete circulatory support. This platform has decades of clinical experience. The first implants occurred in the 80s. The FDA approved the first version of the Syncardia total artificial heart in 2004. And since then, we have treated over 2,100 patients worldwide. This extensive clinical experience provides a strong foundation for continued innovation across the platform, including a fully implantable Emperor total artificial heart and next generation driver technology. Next slide, please. Another important aspect of the Syncardia platform is that it extends beyond the implant itself. The system includes hospital driver systems, portable drivers that allow patients to leave the hospital, physician training programs, and a clinical support infrastructure. Together, these elements form a complete artificial heart therapy ecosystem. This infrastructure has been developed over decades and also represents a meaningful barrier to entry from competitors. Next slide, please. During 2025, the company has achieved several important milestones, and we'll go through these in more detail during this presentation. Number one, we successfully completed our initial public offering and raised approximately $35 million in capital. Revenue increased approximately 12% year over year, driven primarily by growth in the United States, which represents our highest margin geography. Operationally, we continue to develop the development of the fully implantable Emperor total artificial heart program and next generation driver technologies. We have also initiated key manufacturing initiatives, including bringing the valve assembly in-house and advancing driver manufacturing technology transfer. In addition, we made progress towards regulatory preparations for potential NMPA submission in China and other markets. Importantly, the existing Syncardia platform provides a real clinical and commercial foundation as we continue developing the next generation artificial heart technologies. Next slide, please. Our strategy for growth focuses on four areas. First, expanding clinical adaptation by increasing implanting centers and strengthening physician training. Second, advancing next generation artificial heart technologies, including the fully implantable Emperor system. Third, improving operational efficiency through manufacturing optimization and supply chain initiatives. And fourth, expanding global access through additional regulatory pathways and international partnerships. Together, these efforts are designed to expand access to the artificial heart therapy while improving the scalability of our business. Next slide. So with this overview, I will now turn over the presentation to our Chief Operating Officer, Matt Schuster, who will discuss the technology platform and development pipeline in more detail. Matt.

Thank you, Patrick. Next slide. So we've been a technological leader in artificial hearts for over two decades. In 2004, we received our PMA approval, the first and only ever FDA approval for a total artificial heart. 2012 and 2014, we received approvals for our two different drivers. In 2012, it was for the hospital companion two driver system. And in 2014, we received approval for our portable freedom driver system, which for the first time in history allowed patients to go home on an artificial heart. In 2020, we received approval of our smaller 50cc total artificial heart, which has now been implanted in patients as young as nine years old. And now brings us to 2024, where we are developing our next generation technology to be a fully implantable platform, and we call it the Emperor. We've received multiple US patents up to this point, and we have multiple filings in progress. Next slide, please. The Emperor Total Artificial Heart is designed to stand on the shoulders of the technology that we have, particularly our implant for which we have over 2,100 implants worth of experience. And the idea is we are removing the pneumatic external driver system and actuating our heart ventricles mechanically. We are preserving the surgical placement and connections that we currently use and that are proven for the total artificial heart. We instead now are incorporating an internal power system as well as mechanical pusher system to actuate the heart. Ultimately, this will improve long-term mobility and ultimately patient quality of life. And as mentioned, we have multiple patents, particularly three issued US patents and one issued Chinese patent for this technology. Next slide, please. With respect to the mechanism of action, the top two components that you see are for the syncardia total artificial heart pneumatic as it stands. The bottom two images are for the emperor total artificial heart system. They're both volume displacement pumps and therefore both have great afterload independence. As you can see for the Syncardia current version, in diastole, blood enters the inflow valve and fills the blood chamber. And then in systole, we provide a blue pulse of air, which are in those blue arrows. That pulse of air ejects the blood out the outflow valve. You'll see the images below that the emperor total artificial heart uses the same ventricle, the same diaphragm, and blood fills the ventricle just as it does with the currents in cardio heart. But in systole, the difference is instead of air pressure, we're mechanically pushing the diaphragm forward to eject the blood out of the outflow valve. This provides automatic adjustment of cardiac output in response to changes in preload and afterload. And that's done through what we call partial fill, full eject system. By replacing or by moving volumes, we're actually mimicking the physiological pumping mechanism that the human heart itself has. Next slide, please. We've done quite a bit of in vitro and in vivo testing so far. This graph represents some benchtop testing that we have done. And you'll notice on the X axis, this is right atrial pressure. As you move to the right, it increases. And on the Y axis is a cardiac output in liters per minute. And what you'll see is that as the right atrial pressure increases, we get a nice increase in cardiac output. And this is an example of the Frank Starling auto-regulation response. We're not changing, as I said, the blood side of this pump, which is proven and has been implanted over 2,100 times. We'll have an equivalent stroke volume, cardiac output, and wash characteristics. And this last bullet, I want to reemphasize it maintains stable output across a range of physiological conditions. So for example, in a patient that is hypertensive or has high pressure through the lungs, we are able to push through that because we are mimicking the human heart and literally moving a volume of blood on each beat. Next slide. This graph represents in vivo testing that we have done. We have successfully now implanted in multiple porcine models. Every implant that we have now done on porcine model has been successful, meaning we were able to separate the animal from bypass and move the animal to full support on the new emperor system without complications. In all cases, the device provided stable circulatory support during our observation periods and hemodynamic performance was consistent with design objectives and therefore consistent also with the current syncardia total artificial heart system. This plot represents as the one before as an increase in atrial pressure happens, we get a nice increase in Frank Starling auto response in liters per minute. Next slide. Our development roadmap consists of the following. This year, we're continuing our acute animal studies and we're continuing to iterate the design. We will also start reliability testing for a potential submission for an FDA breakthrough device designation. In 2027, we'll be working on completing their design freeze and our initiation of GLP animal studies. And finally, in 2028, we'll be finalizing V&V testing, that's verification and validation testing, with potential initiation of a U.S. clinical study. Note that the Emperor Generation One concept does still contain an external battery component. This component is extremely small, slightly larger than a cell phone. But key point here is that the Emperor system is so energy efficient that it will enable implantation of batteries and therefore be fully implantable in following generations. Next slide. We're also advancing our pneumatic driver technologies. You'll note in this picture, this is a Freedom Driver next to our new portable system that we're codenamed the Unicorn. The Unicorn is significantly smaller, as you can see, and significantly lighter. The efficiency has also been increased to improve battery life. And it also is simpler and uses more modern components. So ultimately we'll have a manufacturing cost advantage through this simplified architecture. Next slide. So in summary, we commercially have the FDA approved Syncardia Total Artificial Heart in both 70 CC volume and 50 CC volume sizes. In development and on bench tests now, we have the unicorn portable driver system. It's our next generation pneumatic system. And we are now at preclinical testing in animals on our emperor total artificial heart system, which is fully implantable and headed for long-term support. Next slide. All right, now we'll talk about operational strategy and our manufacturing initiatives. Next slide. So we start with manufacturing optimization, and that consists specifically now of manufacturing of our current driver systems to China. This allows our U.S. team to focus on implant innovation, particularly the Emperor system. It supports a lower manufacturing cost and reduces our component obsolescence risks. Next, we shoot for vertical integration. We will be doing valve assembly of our artificial heart valve in-house at Syncardia. This eliminates our reliance on an external supplier. It improves our precision control over valve tolerances, which are critical, and it reduces our manufacturing lead time. So we can make our valves to order, so to speak. Supply chain resilience is also important. We are qualifying second sources for critical implant components. This ensures the continuity of implant component supply, of course, and also enables supplier cost benchmarking. Ultimately, we have the ability to price compare and get the best deal possible. Next slide. Now I'm introducing Bernard Skaggs, our Chief Financial Officer. Thank you, Matt.

Next slide. In 2025, revenue increased 12.5% year over year to $4.94 million. This growth was primarily driven by increasing adoption of the Syncardia platform in the United States. U.S. revenue grew approximately 33.5% year over year and represented roughly 88% of total company revenue. Product revenue increased 11.6% to $4.75 million and continues to represent the majority of our revenue. Importantly, the shift toward U.S. revenue is strategically significant because the U.S. market represents our highest margin geography and provides the largest opportunity for long-term growth. Next slide. During 2025, the company raised approximately $35.5 million in gross capital through the initial public offering and institutional financing. The majority of these funds were deployed to support ongoing operations and business growth. Approximately 36% of the capital raised was used to address legacy balance sheet obligations, including repayment of legacy debt and settlement of outstanding accounts payable. The remaining portion reflects transaction and financing costs associated with becoming a public company and securing institutional capital. Next slide. Our GAAP loss for 2025 was approximately $27 million. However, it is important to note that this figure includes non-cash and financing related items. These items primarily reflect derivative accounting and amortization of debt discounts and other financing related charges. After adjusting for these items and working capital movements, GAAP net operating cash was approximately $15.3 million with non-GAAP normalized operating cash burden of $11 million. This figure more closely reflects the underlying operating cash burden of the business. Next slide. Following the IPO and related financings, the company's balance sheet improved significantly. Stockholders' equity improved from a deficit of approximately $44 million at the end of 2024 to positive equity of approximately $3.8 million at the end of 2025. Additional paid-in capital increased substantially following the IPO and financing transactions. These transactions allowed the company to repay legacy obligations and improve its overall financial position. Next slide. This slide summarizes the company's capitalization and fully diluted share count. Following shareholder approval earlier this month, the company increased the number of authorized shares to 300 million. Providing transparency around capitalization and potential dilution is important for investors evaluating the company's financial structure. Next slide. Looking ahead to 2026, our financial priorities focus on four areas. First, continuing to drive revenue growth, particularly through increased adoption in the United States. Second, improving gross margins through scale, manufacturing efficiency, and optimization of our rental programs. Third, discipline capital and cost management as we continue to develop next generation technologies. And fourth, strengthening the balance sheet through additional capital to support operations and continued development of new products. With that overview of our financial performance and priorities, I will now turn the presentation over to Dr. Amy Fiedler to discuss the clinical experience with Syncardia Total Artificial Heart.

Great. Thank you for having me today. My name is Amy Fiedler. I'm an associate professor of surgery and the surgical director of heart transplantation and mechanical circulatory support at UCSF. Next slide, please. So today, it's my pleasure to discuss a cardiac surgeon's perspective of the total artificial heart, how we use it, how it saves patients, and our institutional experience. Next slide, please. So we have some objectives. The first is to give a brief overview of our heart failure program at UCSF. Next, we'll describe our path to total artificial heart and subsequent growth of our program. We will review patient selection, which is arguably the key for success of this device, touch upon surgical technique, and finally discuss our institutional outcomes to date. And finally, next steps for future growth and collaboration. Next slide, please. So our heart failure group at UCSF is a great group of people and we're growing. We are one of the top eight heart transplant programs in the United States based on volume. We represent the largest VA ECMO program in the West. And we're also the fifth largest LVAD HeartMate 3 or a durable LVAD implanting center in the West. This positions us quite well to roll out the total artificial heart. and bring this biventricular support life-saving device to our patient population. Next slide, please. So our journey, our institutional journey to total artificial heart, I will say it takes a team. This device is a device that not everyone is familiar with, and we're lucky that we practice at an institution that has an incredible team already and have always been forward-thinking and innovative in terms of bringing the next and best therapies to our patients. So for us, we're a busy LVAD center. We're a busy transplant center. We have fantastic coordinators and nurses. These are already in place as a result of our transplant program. We have innovative leadership. And finally, we have surgeons with experience. So there's a case report which I published with my partner and colleague, Dr. Smith, with the use of an unconventional use of the Syncardia total artificial heart, specifically in a patient with severe destructive prosthetic valve endocarditis. So we've brought surgical expertise to an institution with a very busy transplant program with respect to the total artificial heart, and that's helped us to build our clinical program. Next slide, please. So patient selection is key for this device. We've heard a little bit about the utility of it, but really what it represents is a life-saving device specifically for patients who have biventricular or both sides of the heart which are failing. Age, age is incredibly important. This device, it's a big operation to put the device in, quite frankly. and it requires a lot of rehabilitation afterwards. I would argue that patients who are on the younger end of the spectrum usually do better with this device than the older patients. The status of end organs, by that I mean the kidneys, the liver, the brain, we need to make sure that they go into the operation with end organs which are being perfused. This device does very, very well in patients who have isolated biventricular heart failure. Next point, a multidisciplinary evaluation. So many folks on the call are very familiar with the multidisciplinary evaluation of a patient who's looking for advanced therapies or heart transplant. We utilize the expertise of every individual on our team to decide if a patient is appropriate for the implant of a TAH. And then potential transplant candidacy in the future. This is very important because the device is right now only approved for patients as a bridge to heart transplant. So when we implant the total artificial heart in patients, we need to be sure that they are possibly a transplant candidate in the future. And rehabilitation potential. This ties into age, status of end organs, et cetera. We want to be sure that these patients that we implant are able to get out of the hospital and live long, full lives. Next slide, please. So we can advance. So a young patient, someone like this on the left, is someone who we would favor for implanting the device as compared to an older patient who may be more frail. We'll have a much better outcome when we implant in the younger patient. Next slide, please. So surgical technique, I recognize I may be one and Zane is the only surgeons potentially on this call. So I'll I'll be brief for this, but the photograph represents the native ventricles that are excised at the time of the total artificial heart implant. With respect to surgical technique, there are some aspects that you can do in the operating room that not only help you implant the device in a very smooth and reproducible manner, but additionally set you up for when you take that patient back for the reoperation for the subsequent heart transplant that leads you to success. The things in my experience that allow us to do that is to minimize unnecessary dissection. We sew the grafts to the aorta and the pulmonary artery first. We reinforce the ventricular cuffs with two layers to minimize bleeding. Bleeding is one of the Achilles heels, surgically, of the device. We place loops around the structures that need to be easily identified at the time of reoperation, and we reconstruct the pericardium or the covering of the heart with Gore-Tex, and we close what we can of the native pericardium in order to ease our reentry when we bring our patients back for heart transplant. Finally, we leave the chest temporarily open until we are exquisitely dry from a hemostasis standpoint. Again, this helps with... adhesions and our ability to move forward with a reoperative sternotomy and heart transplant in a very reproducible and safe manner. You can move to the next slide, please. So at UCSF, our institutional outcomes to date are something that we are very proud of. Our program began in 2024, and here you see an amazing photograph of the first patient sitting there in the wheelchair who we implanted with the total artificial heart device. Since November of 2024, we've implanted five devices. Two of the five patients moved forward with successful heart transplant. One is awaiting discharge from the hospital, and two have passed away. Based on publishable data, this represents a robust center of excellence, and we look forward to continue to grow our total artificial heart program with continued success. We can move to the next slide. So here are a couple success stories. These are two of our patients. Actually, both have now been subsequently transplanted. And you can see here as we play the videos, they look fantastic out of the hospital, walking through the halls with their freedom driver, rehabbing, getting back to their normal lives. And the TAH has allowed them to do that. Without the TAH, these patients would not be with us. can play the next video.

Hey Martel, keep going, man.

You're doing great.

Thank you so much.

You're welcome, sweetheart. So something I would say is that these patients are some of the most grateful patients because they come to us really in extremis and we're able to, with the use of the TAH device, really give them their lives back. So we can move to the next slide. Again, just success stories. This was actually featured in the local Bay Area news. Martel, the last video that you just saw, he was our first patient that we implanted with the TAH and took successfully to transplant. So really that's the full arc of taking a patient from the device to transplant. And there he is with his young daughter living his life and it's phenomenal to see. You can see in the next picture, that's our most recent implant walking the halls in the ICU and preparing for discharge. Can move to the next slide. So next steps for growth and collaboration. As I've said, we've only had five implants so far, but that's actually a lot when we look at the number of implants to date across the world. So we're looking to become a destination center for the total artificial heart. We're looking to partner and we continue to partner with Syncardia for collaborative outreach events across the country promoting the total artificial heart and collaboration with UCSF. We're partnering with Syncardia as well as some of our research fellows to publish outcomes, best practices, and practice changing techniques. And finally, there may be an opportunity for cross-collaboration across institutions and perhaps even industry to identify those patients who are undergoing isolated durable LVAD implant that have RV failure postoperatively and select those patients perhaps more appropriately for an implant initially of biventricular support like the TAH as compared to an LVAD implant. We can move to the next slide. So thank you very much. This was Martel, the gentleman you saw in the video. This is right after he had his day one actually after the TAH was implanted. You can see the breathing tubes out. He's giving a thumbs up and he's feeling great. Thank you for the opportunity to speak today. I'd be happy to answer any questions at the conclusion of the program.

Hi, my name is Marcela. I'm 36 years old and my journey began after the birth of my son. Four days after healthy pregnancy, everything changed. I couldn't breathe and my feet were really swollen. I felt like my life was slipping away. I was diagnosed with postpartum cardiomyopathy, and despite multiple medications, my heart continued to fail. What made this journey even more challenging is that my condition is genetic. Heart disease has deeply affected my family. My father and my twin sisters have also undergone heart transplants. While this was overwhelming, it also showed me the strength we carry as a family. Doctors decided to implant an artificial heart. Those first days were very difficult, but little by little, I regained strength and hope. The device gave me a second chance. It allowed me to watch my son grow and to spend precious time with my family. During the months I spent in the hospital, I learned how fragile life can be. My survival depended on electricity. Yet I faced it with courage and determination. When I finally went home, I embraced it with fully going to the park with my son spending time with my family and appreciating the small moments that make life so meaningful. After almost nine months, I received my heart transplant. The moment marked the true beginning of my second chance at life. Today, I stand here as a living proof that even in the darkest moments, there is hope. I continue to be a wife, a mother, and someone

who chooses to live life to the fullest every single day. Thank you.

Thank you. Well, I think that's the reason why we do this. And Marcela, it's beautiful to hear from you. And Dr. Fiedler, it's really impressive what you and your program have been doing. Next slide, please. It's, Mr. Chairman, and ladies and gentlemen, it's a privilege to talk to you today. I really appreciate this opportunity. And what I really want to do over the next 10 minutes is to walk you through where I think mechanical circular support stands today and where the critical unmet needs are and where the technology is actually heading, specifically around the total artificial hearts and the EMPRA platform. I just want to emphasize that this is a physician's perspective. I've implanted many of these devices and I manage many of them post-operatively. I've actually watched this field evolve considerably over the past two decades when I had the dream to come to Arizona to actually be here. And sometimes things go in the right direction, but sometimes not. So I want to be direct about what is working, what's not, and what I believe needs to happen next. So let me start with the landscape. Next slide, please. This is the 60-year arc that Amy and myself are probably familiar with. It starts off in the 1960s with the intra-aortic balloon pump and then the first-generation pulsatile vats in 1990, where I was working with Sir Magdy Akum in the United Kingdom and at the Brigham, where both Amy and I trained. And, you know, continuous flow devices came alive in the 2000s. But what really changed it, I think, for me, was the total artificial heart and now the next generation fully implantable systems. Each of these was a really meaningful advance, but each one of these also introduced a new set of problems. Pulsatile LVADs solved durability, but were large and mechanically unreliable. Continuous flow devices solved the size issue but eliminated pulsatility, and with it came GI bleeding, pump thrombosis, and aortic insufficiency. The total artificial heart addressed biventricular failure but required an external pneumatic driver. The pattern is consistent. We solve one generation's limitation and create the next one. This is the honest reality of where we are. Another six decades of engineering, we still do not have a durable mechanical support device that allows patients to live a normal and, like Marcella now, untethered life. So that gap between what we can offer and what patients actually need is a central issue. And it is the reason this conversation matters. Next slide, please. I want to be clear. I am not here to criticize LVAD therapy. I implant LVADs regularly. They work for isolated left ventricular failure. They remain the standard of care, and the outcomes are extremely well established with the Momentum 3 trial. But the data is also clear on the limitation. Post-LVAD right ventricular failure occurs in 20% to 40% of cases, and that's not a marginal number. That is a substantial portion of our patient population for whom we do not have an approved curable solution. It's frankly a pain for Amy and me to have to deal with that right-sided failure when you've got a beautiful LVAD sitting there. So what happens to those patients? Well, we escalate to temporary support, like an impeller on the right side or ECMO or temporary surgical right ventricular cyst devices. These are crisis interventions. They were not designed to be definitive therapy. And in many cases, we are bridging patients without a really clear endpoint. Not to transplant, as the organs are not available. Not to recovery, because the data does not support that expectation in most of these patients. We're managing a crisis without a plan or resolution. So the escalation pathways remain fragmented. They are reactive rather than strategic. And the outcomes for this biventricular fitna population remain significantly worse than what we achieve with isolated LVAP therapy. So the bottom line is we're still reacting to failure rather than addressing it with a planned durable intervention. Next slide, please. Well, this is where the total artificial heart fits in. And I would argue it fits more precisely than many clinicians currently appreciate. And it became very, very clear to me when I did the first 50cc total artificial heart in North America in 2015, 2016, in a beautiful 19-year-old girl who later went to get a transplant. And the total artificial heart provides a complete cardiac replacement. There is no residual myocardium to fail, no right ventricle to decompensate after an implant. Its systemic and pulmonary flow are balanced by design. It's not dependent on a native cardiac function. And the clinical data to support this is that 79% bridge to transplant survived. Documented end organ recovery like renal and hepatic in patients who were trending in the wrong direction on temporary support. The appropriate patient population is well defined. Biventricular failure, like Amy said, failed left ventricular assist devices requiring escalation, and complex anatomy cases that do not fit the conventional LVAD algorithm. These are not rare patients. Every high-volume center encounters them regularly. The key point I want this group to take away is that the Syncardia Total Artificial Heart should not be positioned as a last resort. It is most effective when deployed strategically, and that's why we were successful in Arizona. And it should be as a planned intervention before the cascade of multi-organ failure narrows our options. The earlier we integrate it into the treatment algorithm, the better the outcomes. And the data is consistent with this. Next slide, please. Everything I've outlined, the biventricular gap, the limitations of current escalation pathways, the clinical value of the total artificial heart, points to clear next steps. And that's a fully implantable, intelligent total artificial heart. The EMPEROR platform is designed to address this. It's smaller device profile, which broadens patients' eligibility, including women, and smaller frame patients who are currently excluded from a TH therapy. There's no external driveline, which eliminates the percutaneous infection risk that remains one of the most significant complications across all durable mechanical support. The element I find most clinically significant is the integration of AI-powered intelligent controllers, not fixed output devices, but systems that adapt to physiological demands in real time, like a walk, like a run. That is a fundamental shift in how these devices operate. The strategic implication is straightforward. We move from using the TH primary as a salvage therapy, which everyone's doing, and intervene when the patient is already in a crisis, to deploying it as a planned strategic intervention. And the long-term trajectory is destination therapy, just like Amy said. it's not exclusively as a bridge to transplant, but a durable solution that makes transplant unnecessary for an appropriate subset of patients. That is the direct thing. Fully implantable, intelligent, strategic rather than reactive. Next slide, please. So let me close with the specifics of the EMPRA, total artificial heart. This is a fully implantable electromechanical artificial heart system like Matt Schuster said. It's currently in early engineering and preclinical evaluation. This is very, very exciting for me. It is designed to preserve the hemodynamic performance and physiological autoregulation of the syncardia TH, which already has a proven clinical track record, while eliminates the external driver entirely. From a clinical perspective, there's about five reasons I believe this platform represents a significant advancement. First of all, its usability. The device is designed for the implanting surgeon, not the engineer. And importantly, future iterations will have no driveline and no break in the skin. This is a fundamental change in the infection risk profile that we currently have. Secondly, the battery life. The efficiency improvement is high in order of magnitude. That has a direct impact on patient quality of life and caregiver burden. It changes what daily living looks like for these patients. Thirdly, simplicity. No more separate hospital and home driver units. No more training families on pneumatic console management. One integrated system. Fourthly, it's silent. There's no clippity-clop that you heard in the video just a short time ago. No mechanical noise. Patients on current devices live with this constant audible reminder of their dependence on a machine. Removing that has real psychological and quality of life implications. And lastly, mechanical actuation allows for finer motion control that pneumatic systems can't deliver. And that translates to more precise hemodynamic management and better fill sensing capability, just like Matt Schuster was alluding to. So the target population is biventricular failure patients who currently have no durable solution. The Emperor is designed to give them one. I'm so excited that this is going to happen. So thank you for the privilege. I'm very happy to take questions at the end of the Q&A. Thank you.

Thank you so much, Zane, Amy, and also Marcello for the very emotional story. So I'm going to wrap this up here and make an intro into the Q&A. So to conclude, let me briefly highlight the priorities of Syncardia Picard as we go into 2026. First, we expect to continue expanding the adaptation of the current Zuccardia platform, particularly in the United States, which remains our most important market. Secondly, we will continue advancing our next generation technologies, including a fully implantable EMPR, total artificial heart, hopefully along the lines as just described by Zane. At the same time, we're implementing operational initiatives across manufacturing and the supply chain aimed at improving efficiency and strengthening the resilience as the business grows. We also are continuing to invest in physician training, clinical adaptation, and support the expansion of implanting centers. Finally, we remain focused on strengthening our balance sheet, securing the capital needed to support both operations and continued technology development. Overall, I think what we're doing is pretty straightforward. We want to expand access to artificial heart therapy while continuing to advance technologies that will ultimately provide alternatives to heart transplantation. Again, thanks everybody here in the, I guess, on Zoom for presenting. I'm thanking our physicians, our patients for coming here, LifeSci for sending this up. And I thank the audience for joining us today and for continued interest in PCAR Medical. I appreciate, we appreciate the opportunity to share our progress and strategic priorities with you. At this point, I will turn over the call to Dory, a life scientist who will moderate the question and answer session.

Thank you. Thanks, Patrick. So our first question is from Ryan Cooney at West Park Capital. And it's what, excuse me, which procedural milestones can be viewed as inflection points as Picard advances in development, the emperor, total artificial heart?

Yeah, I think I can help answer that one. With respect to the emperor development, big milestones to watch for are animal implants and the data that we get from that. So we have acute animal studies planned for this year. With each study increasing in complexity, And therefore, we'll be getting even more detailed and significant data. So watch for that as we move forward. Beyond that, it will be GLP animal studies, good lab practices studies, which we will coordinate with the FDA to plan those studies. And then beyond that, it will be first in human.

Great. Thank you, Matt. Next question is from Yi Chen at HC Wayne, right? How many active implanting centers do you have today? And how does that compare to two to three years ago? Is the constraint supply, surgeon training, hospital certification or reimbursement a factor in this?

Yeah, I can, I can take that question. Thanks so much for your question. So number one, we, we have currently the past 12 months around 20 active centers, or 20 centers that have implanted dysoncardia to a lot of visual heart. the majority in the U.S. That is quite a bit lower than we used to have it several years ago. But that's really the result of us focusing, having shifted our focus back from outside of the U.S. on centers here in the U.S. and growing those centers. The second part of the question, what was that? Sorry.

I'm so sorry. I think it's hidden now, but I think it was, you know, what factors are contributing to that, the constant constraint supply, surgeon training, hospital certification or reimbursement?

Yeah, so I think the biggest constraint to growth is awareness, search and training. Reimbursement is not an issue. We are fully reimbursed. Supply is not an issue. We're managing supply adequately. And so that's why, as we have stressed in our presentation, I heavily focused on increasing, obviously, while... Focusing on our pipeline, also increasing the awareness to scientific publication, to being present at Congresses, and to working with centers like UCSF, Banner, and other centers here in the United States.

Great. And Yi has a second part to the question. Is the Emperor also audible? Is that a design criteria you find patients are concerned about with the current system?

I'll take that quickly. Matt, if you have additional comments, chime in. So no, the device is not audible. This is no longer a pneumatic system. So you will not hear the air flip-flopping the diaphragms. It is an electromechanical system. The motor is completely silent. So that's a huge difference. And in patients, you know, it is the current pneumatic driver system. It's audible. Anecdotally, there are patients who, after they have received their donor heart, were actually quite concerned because they didn't hear the noise anymore. So clearly a form factor that we want to get rid of. But I don't think I've, you know, Not heard. This is a showstopper for therapeutic use of the Synchronic Total artificial hunting noise. But for sure, the Emperor will not have that issue.

Okay, great. Another question that came in on the platform is what differentiates Picard from other mechanical circulatory support companies that are out there?

You want me to? Matt, why don't you get a stab at that?

Yeah, happy to. And of course, you can fill in. I would say what separates Picard from other mechanical circulatory support companies? I would say it's that we're the only ever FDA approved biventricular total artificial heart developer. So we have our therapy is biventricular, as we mentioned. It's pulsatile. And I would also say, importantly, it's afterload independent. So it is very important that we're squeezing or moving those volumes of blood, just like a human heart, rather than continuous flow type technologies. So those are the two keys I would say is a truly pulsatile volume moving system, as well as actually the only FDA approved biventricular total artificial heart system.

Okay, great. Thank you, Matt. Another question came in. Maybe this is for Dr. Fiedler. Which patients benefit most from the Syncardia Total Artificial Heart Therapy?

So a great question. I think I'll echo what everyone else has said. Patients who require full biventricular support in a manner that allows them to be discharged from the hospital to go out and live their lives. So Biventricular failure patients are the patients that benefit the most. And I would move ahead by saying that those who do best with the total artificial heart are those who go into it looking relatively robust, meaning we can put the device in, they can recover from the surgery, and they can get out of the hospital and go about living their lives. So again, age is important. medical comorbidities, the support of their end organs prior to the implant. Those are the patients that really do the best.

That's super helpful. Thank you, Dr. Fiedler. Okay, here's another question. Also, why are LVADs insufficient for many advanced heart failure patients? Maybe Dr. Kalpe, you can answer that one.

Yeah, that's a great question. You know, sometimes there's a lot of issues. LVADs are a fantastic therapy, but one of the key things is when your right heart is failing or you have an arrhythmia, such as ventricular tachycardia, but it starts originating and the right heart starts to suffer, you start developing an inefficient system and you lose control with how much you fill the LVAD from the right side. So typically, you want to have control. And it's not that we're all control freaks. It's just the fact that it's better physiology. And I think that having the right and the left side in control can make it, you know, you're now suddenly off all drips, which are not squeezing every other organ in the body. You are just having pulsatile flow, which goes across and you recover your kidneys, I think, much quicker. Yeah. And honestly, I think it's a much cleaner way to, and as Amy said earlier, if you plan this well ahead in younger patients, they do really, really well, rather than the crisis patients who are crashing and burning. And so I think it's really important to identify these, just to the earlier question, I think it's really important to identify these in people who have mitral valve disease with a burnt out heart and just very thin muscle from ischemic cardiomyopathy. I think you've got to be really thinking ahead with a heart that's peppered in scar that has substrate for things like ventricular tachycardia. You've got to be thinking ahead that, you know, this is a better solution because you're going to have problems later on with LVAD. And, you know, when I was at the Brigham, then I went to Columbia and I was rounding out of the 16 LVAD patients, about four had temporary RV support devices. And those patients were in much, much longer. So the hospital stays are much longer. So I don't want to have these kind of things lingering because your outcomes are going to be poor. And so this really, if planned well, you would be able to get them to a transplant or, as we hope, a destination therapy. So I hope that answers the question.

Yeah, I think so. And one just came in. Maybe you can also answer, Dr. Kalpi. Could artificial hearts eventually become long-term therapy rather than a bridge to transplant therapy?

Imagine this, right? So when you have a transplant, you are going to be on immunosuppressive drugs for a very, very long time, almost all your life, because you have to. What does that include? That includes steroids, includes medications or calcineurin inhibitors, which affect calcium metabolism, And eventually, you're going to be having that organ having something called chronic allograft vasculopathy. Eventually, that heart, if not had when you were transplanted when you were very, very young, doesn't accommodate. So the antibodies cause rejection in the transplant. That's why I'm answering it in a reverse engineered way. When you have a total artificial heart, the cool stuff that's happening now in this world is AI. And, you know, I'm not a paid consultant for psychiatrists. I'm going to say what I like. But the cool thing is, is that artificial intelligence will make this artificial heart much more smarter. And the Emperor device coming along is, will really allow us to be a little bit more intelligent when you want a patient... When you're lying to standing, the amount of physiological changes that go on, rather than just having a set volume of blood being squeezed, is not as physiologic as you like. So the heart will actually be more intelligent if... the intelligence in the system which Sankari is developing will actually, I hope, be much more physiological, smarter, cooler, and easier with less complications and much more physiologic. And if it's totally implantable, you wouldn't even know if you've got the difference between a heart transplant or a total artificial heart, other than you won't be taking those horrible anti-immunosuppressant drugs. And frankly, I'm a tech guy and I love this kind of stuff. So for me, it would be a dream come true in my lifetime if we have a totally implantable total artificial heart, which is intelligent. So I hope that answers the question and gets away from transplant where there is, you know, We're now trying to rekindle, re-manicure, recover kind of subpar B organs to A organs to transplant them because there isn't enough of the donor supply. So this takes care of it off the shelf, frankly, like a valve that we put in every day.

That's super helpful. Thanks for that perspective. Here's another question. What clinical outcomes have been observed with the Syncardia total artificial heart so far? Maybe Dr. Fiedler, you want to take that one?

Sure. I think Dr. Colby showed some data there, 70 plus percent implants of the Syncardia TH move ahead to successful heart transplant. That's a really remarkable number when you think about it. There's a lot of things that can always go wrong when patients are being kept alive with the machine. And to have that large amount of success moving forward to life-saving heart transplant, which is at this point gold standard definitive therapy, is exceptional. And I think that's probably the most important statistic for us to recognize as the device currently stands. As Zane was saying, and the prior question, we're living and working in a really, really exciting time for heart transplant, mechanical circulatory support in heart failure patients. The possibility of having a fully implantable total artificial heart, which can allow patients to have a durable biventricular support device would revolutionize the field. The inability, you know, not having to take immunosuppressive medications, not having to undergo another operation to have a heart transplant. These are all things that can be transformative in patients' lives when previously we didn't have a lot of options. So I think we're functioning right now at a time where the field is really driving forward and it's an exciting time to be involved with it.

That's amazing. Okay. I think if there's no more questions, I think that is a wrap. And thank you so much to both key opinion leaders today and also to patient Marcella and for Syncardia.

Yes.

Thank you, everybody.

Thank you.

Thank you.

Thank you. Thank you.

Thank you.

Thank you.