Good afternoon, everyone, and thank you for joining the 2025 H.C. Wainwright 27th Annual Global Investment Conference. I'm Jade Montgomery, an Associate Biotech Research Analyst at the firm, and I'd like you to please join me in welcoming Patrick Schnegelsberg. Sorry, I probably butchered that again. CEO of SynCardia Systems LLC, a Picard Medical company. Patrick.
Thank you so much. Appreciate the opportunity to present here. I will give you a quick overview of Picard. Picard Medical is a company that we listed a couple of weeks ago on Nasdaq, under the ticker PMI. We actually closed an over-allotment option, and so we raised in total about $19.2 million in our IPO. Picard Medical is the parent company of SynCardia, and I'll be making, as I go through this, a couple of forward-looking statements. The mission of SynCardia is really to pioneer the future of heart replacement, and that's by two means. Number one, promoting and selling our current total artificial heart. That's FDA approved, and also by developing a next-generation fully implantable version of the SynCardia Total Artificial Heart. Let's have a quick look at the team. Myself, I've been with the company for two years.
I bring 25 years of MedTech executive-level experience to the company. I've been most of this time in the cardiovascular space, in Class III medical devices, mostly implants, some minimally invasive, and some surgical. I've also served on the board of Scandinavian Real Heart, another total artificial heart company, and I'm currently also on the board of Acorai, a company developing a non-invasive blood pressure monitoring device. On my team is Matt Schuster, Chief Operating Officer. He has been with SynCardia. He joined SynCardia or rejoined SynCardia in 2003 as well. He was before that at SynCardia in manufacturing and managing the plant. He's also spent some time at Roche, has started his own medical device business, and as I mentioned, he's currently the Chief Operating Officer of the company. He's also the inventor of the IP around our fully implantable version of the total artificial heart.
Finally, Bernard, he's our Chief Financial Officer. He got his original training at Deloitte, spent time in various financial positions at aerospace and pharmaceutical companies, and Bernard also joined in 2003. So we're a relatively young team in terms of the company's history, but all of us are extremely committed to the growth and development of SynCardia. What do we do? SynCardia is the market leader in total artificial heart technology. As I mentioned, we're a wholly owned subsidiary of Nasdaq-listed Picard Medical. We have the only FDA-approved total artificial heart. There's no other total artificial heart that has been approved by the FDA at this time. We're also approved in Health Canada, and to this date, we've performed over 2,100 implants with the SynCardia Total Artificial Heart in 27 countries around the globe. That equates to somewhere around 800 patient years of experience. This is a potentially life-saving therapy.
We replace both ventricles in patients who have end-stage heart failure, and typically the only way out for these patients is a heart transplant. So the problem here, I just alluded to it. There are probably around 300,000 patients in the United States alone each year that qualify for advanced heart failure, advanced stage heart failure patients. Many of these patients move on to needing a heart transplant. They will exhaust all pharmaceutical and medical device therapies that are out there. But at the end of the day, there's only around 7,500 patients in the United States each year who qualify for the transplant list, i.e., those patients are "healthy enough" to receive a donor heart. Of those, only 4,000 or 4,200, depending where you look, each year actually receive a heart transplant.
That leaves basically a population of somewhere between 3,000 and 3,500 patients each year in the United States who do not get a heart transplant. The majority of these patients will get off the heart transplant list because they advance in disease, they get sicker, or they will die. And so this is where we come in. We provide them a bridge to transplant. These patients can receive a SynCardia Total Artificial Heart and thus extend their life and their expectations to receive a heart transplant. In many cases, these patients also will recover and actually become better so that they can requalify for the list. How do we do this? Our device is currently indicated to replace a failing heart, so as a bridge to transplant. So it's important you need to be or you should be on the transplant list, so in the 7,500 patient group.
The device has three components. One under the red box here is the implant. We have two sizes. The implant will be replacing the diseased heart almost entirely. We're taking out both ventricles, all valves, and then basically connect either a 70 cc or a 50 cc ventricle to the rest of the circulation. The system is pulsatile, so it works just like the normal beating heart. It pumps the blood in a pulsatile fashion through the cardiovascular system. This is different from many other mechanical support systems, which are not pulsatile. And we do believe that pulsatility is a key factor to improve organ functions and to improve the health of patients. The other two components are external. There are two drivers. The light blue is the C2 driver that is designed for in-hospital use.
Number one, it's used in the ICU where the patient is immobile, but then as the patient becomes better and recovers, or called ambulatory, the patient can move around with a little caddy, as shown in a little cartoon there in the upper right circle, and they can recover as they walk around in the hospital and go through cardiac rehab. The third component is the Freedom Driver all the way on the right, and that is intended for home use. So with this driver, patients can be discharged from the hospital and go home and lead a fairly normal life. We have seen patients riding ATVs, playing golf, hiking, walking around, and pretty much going about their lives as normal.
The two drivers, they are pneumatic pumps, so they take air, pump it to drive lines that connect through the chest, through the implant, and as I mentioned earlier, in a pulsatile fashion, deliver pressure so as to actuate the heartbeat. This technology is based on 20 years of development. The first version of the SynCardia Total Artificial Heart was approved in 2004 after a randomized and the only randomized controlled study ever done with a Total Artificial Heart. That was the 70cc device with a fairly large driver that was not suitable for out-of-hospital use. In 2012, then the company developed the companion C2 Driver or the C2 Driver intended for in-hospital use as well as ambulatory, so stationary ICU, as well as stationary in-hospital use.
In 2014, a major breakthrough again, the FDA approved the Freedom Driver, and that allowed the patients now to be discharged to home and, as I mentioned, to live a normal life. And in 2020, the smaller version, the 50 cc of the implant was approved, and so that enables us now to treat probably or to implant the device in probably over 90% of the population in terms of body size, height, and whatever dimensions you may have. That's a key distinguishing factor to many other or to all the other total artificial hearts in development that are typically too large to implant in smaller patients. And in 2024, we have started really based on Matt Schuster's IP to develop a fully implantable version of the SynCardia Total Artificial Heart.
And the idea is here that we're leveraging the structure and composition and performance of the implants as we have them today, but we're removing the need for an external pneumatic driver. So the implants will maintain pulsatile function, their geometry, their composition, and everything stays the same. And the only difference will be that they'll be powered by or actuated, I should say, by an internal mechanical motor that's fully implantable and that sits underneath the two ventricles. Clinically validated or our process, our device has been clinically validated. The top two lines show you results from our randomized controlled study. Again, so randomized controlled study means carefully picked patients, right? We got 79% survival rate to transplantation versus 46% in the control group. The control group obviously didn't get a total artificial heart. They were treated with best standard care at that time.
Also in that study, 70% survival at one year in that group, again, versus 31%. So that's both almost a doubling of survival versus the alternatives. These data, as the gray bar shows, have been validated within real-world data, and this is data from over thousands of patients here, 75% survival rate and one year after heart transplant, and that's really important here. That's really also a big measure. How well do you do after you have received a heart transplant, not just only the SynCardia Total Artificial Heart? So in total, this demonstrates that this is a that our heart works, it performs well, and it saves the lives of 75% of patients who, in many cases, really do not have an alternative except death, pretty much. Over 2,100 patients treated, as I mentioned.
We have treated patients as young as 10 years old, and we have obviously treated sort of the standard population somewhere between 50-60 years old, mostly male. Cardiovascular heart disease affects mostly males, and the patient that we have, one patient who is actually still alive, has been on the SynCardia Total Artificial Heart over 7.5 years. We are present today at a number of high-volume centers in the United States. We've also been used outside of the United States, as shown at the bottom, and our goal is really to continue building these centers of excellence in the United States and outside of Europe going forward, but this is all data. I think the important part here is patients, and I just want to show you two stories here. Here's a story of Levon. He's a 10-year-old kid, was diagnosed with myocarditis.
There was no alternative but a heart transplant, but no heart transplant was available. So we were able to help out by providing a SynCardia Total Artificial Heart, and he was, after a short period, on the heart transplanted, 24 days, but it saved this little boy's life. It made a huge difference. The alternative for this boy would have been death. We had our team go there. It was a fantastic story, and he was doing really well. As you can see, we gave him a little Iron Man there. You can actually in that circle in the blue box, that's the heart that saved his life, and we made him a little box there. So very moving story. Different story. Here's Johnny. He had a congenital heart failure and also had no other choice but a heart transplant while he was waiting for a donor.
He was over two years on the SynCardia Total Artificial Heart, but it also changed his life dramatically. It allowed him to see his family's wedding or part of his family's weddings and basically, as you can see here, live a pretty full life while he's on the Freedom Driver. He's playing golf and walking around. Today, Johnny has, or after that, Johnny founded A Unique Beating Heart. That's a patient support group, and they work closely with families, patients, and also healthcare practitioners around the SynCardia Total Artificial Heart to help them educate what the impact on lifestyles are, psychological impacts, and other considerations that families will face when they're faced with the decision of having a heart transplant and also looking at the SynCardia Total Artificial Heart. We are working closely with them to support patients and healthcare practitioners at our sites.
Our sales last year, we had $4.4 million in sales, a little bit over 30 devices sold. That went down from $5 million the year before, and that's basically due to that we focused on restructuring our entire sales organization. We had a very small sales organization dependent on a distributor. We shifted that model, and I expect this year to be on par, if not better than 2023 in terms of sales numbers. We have a number of growth drivers. Number one is really the United States. That's our primary market. We're looking here to physician education and enhancing access and improving our reimbursement, specifically on the drivers, to increase our market share and grow our market share. That's really, so for the time being, the primary growth driver on sales. Midterm growth driver, we have international expansion and label expansion.
Internationally, we are applying for a CE mark that probably will be submitted by year-end, and I would expect an approval of that CE mark somewhere in the last quarter of 2026, early 2027. And we're doing the same thing in China. We have a sister company in China, SynCardia Medical Beijing. One of the objectives of SynCardia Medical Beijing is helping us to gain approval in China. Timelines are comparable to those in Europe. We're going to submit later this year and then also expect our 12-18-month review cycle by NMPA if we go sort of on standard data. And last but not least, we're talking to the FDA here in the United States to work on a label expansion and improvement to also include patients beyond the bridge to transplant indication. But these are all midterm drivers.
Again, they will kick in sometimes in the latter half or early of 2026 or early 2027. Long-term, the driver is really innovation and specifically the fully implantable version of the heart. We call this the Emperor, and our goal is to somewhere in the second half of 2028, early 2029, submit this to the FDA for an approval. And again, that device does not rely on external drivers. It'll be fully implantable and early generation. It may have an external battery still, but ultimately we want to have a TET system that is fully implantable. There's a lot of alternatives, advantages, obviously, of having a fully implantable device. We're also working on improved pneumatic drivers in the meantime, basically to increase the efficiency of these drivers and to improve the performance and to reduce the cost. And we're working closely together from our facility with our colleagues in China.
The idea is to do most of the driver development and production in China so that we can serve the markets here in the United States, in China, as well as in Europe. There's competition out there. As I mentioned, we are the leader. We have the only ones approved in the United States. CARMAT, the second one in the table in the middle, that's a device that is CE marked. They just actually recently also received the MDR CE mark. Here, it's still in progress, but it's been updated. They have about 110 or so implant experience versus our experience of over 2,100, so we have a lot more experience. CARMAT's device is significantly larger and heavier than ours, almost three times or over three times the weight of our devices. Our device basically can fit men, women, and children. CARMAT will not fit all patients.
BiVACOR is another device in development. They have not been approved anywhere. They completed an early feasibility study for five patients. They have also done two patients in Australia. The longest patient they have ever had on the devices is a patient in Australia for 100 days. The patient in the U.S. early feasibility study were on the device for, I think, max. The longest was 27 days. They are also relatively handpicked healthy patients, but they are coming. CARMAT, they are developing this device also slightly heavier and of importance. It is not a pulsatile system. Both CARMAT and SynCardia have a pulsatile system. There is also a functional differentiation among these hearts. For now, and for the foreseeable two or three years, I believe we are going to continue to be the leader here in the United States.
So to summarize this, SynCardia or Picard is the leader in a high-demand market or a high unmet medical need market. We can address a large number of highly underserved, very sick patients. There's a huge potential. As I just told you, we tapped into probably 30, 40 patients of a market potential of 3,500. We have been validated by the market. There's lots of clinical data. We have competitive advantages in terms of development statuses. We're fully reimbursed in the United States. Reimbursement can go as high as almost $430,000. And we have a number of solid near-term, mid-term, and long-term drivers. Thank you. Fantastic. Thank you. I'm going to say no. How long is the artificial heart?
Is there, given that you're applying for approval for an SMAP bridging, what is your thinking around this potentially being a long-term solution?
So this patient is obviously sort of an outlier on the bell curve, right? So just focusing quickly on this patient, this patient lives in Serbia and is basically not eligible for a heart transplant as a result of lifestyle. So that's the short answer of that. Obviously, there's a gagazillion of factors that affect your eligibility for receiving a heart transplant, right? And so that's that. In terms of our strategy, we are looking for a label expansion, as I mentioned, to include destination therapy or long-term. We are obviously talking to FDA about that. We've gotten some very constructive feedback from the agency. We have a good set of data that can support long-term in terms of clinical data that needs to be collected and cleaned out.
We also have from a non-clinical angle that patient we just talked about the heartbeat in that patient for well over a billion cycles, right? If you think about that. Our devices, we have durability testing that exceeds five plus years. So they've been running on mock tanks to monitor the performance of these devices with zero failures. So I'm very confident that from a device design durability angle, the implant will support long-term or the SynCardia Total Artificial Heart. And that's also important for the future because we're using the same platform as a fully implantable device, right? So obviously, durability of the device, the mechanics, the valves, the diaphragms that needs to hold up. And that's also a key feature here. us versus the rest, we have seven or eight parts in this heart. All others have 100+ parts, right?
Even our fully implantable version will not have more than 20 parts the way it's been designed. If you don't count all the screws in the motor, obviously, but in terms of the mechanical parts that need to move. So it's a very, very simple design. Anyway, I said much more than you asked for, but.
I mean, they don't record the questions. So I'll clean up. Great. Okay. You're fine. You mentioned people playing golf and hiking. Does the pulsatile function, essentially, does the frequency of the heartbeat increase?
So that's a really good question. There's something called the Frank-Starling law, which everybody here in this room knows. Basically, it's a formula or a physical law that how your closed circulatory system regulates itself, right? You have the heartbeat, you can expand your vascular volume, the bed, and etc .
That effect is basically what we're using to regulate the heart. You do set the patient at a certain heart rate based on when they're in the hospital, but then it's pretty much auto-regulatory. The heart, the implant itself also has something that's called partial fill mechanism. The idea here is that the heart will never completely fill. That also gives you extra room as you're exercising or so as the demand of the heart increases. In short, it's auto-regulated by your body. We set it up and kind of sort of calibrate it in the beginning, and then you're good to go.
Yeah, no problem. When you're talking about that in terms of the regulation, is the AV node, is the motor a constant speed, or does it speed up as you exercise? Like when you're saying it's auto-regulated.
Yeah, so the motor, the pump pumps at a constant speed. It's set at a certain heart rate. But how your body compensates to it is because you have the partial fill of the ventricles. They're never completely full, so they can accommodate. And then it's the Frank-Starling effect that will work the whole cardiovascular system to fill and empty the ventricles. But the heart rate will always be the same. When you exercise, the problem you run into is that you get lightheaded because you don't get enough, for example, blood to your brain or something like that. And again, the combination of the design, how the physics or the mechanics of the ventricles work, plus the inherent existence in your body of the fact of the Frank-Starling law, that will compensate for that.