Let's go ahead and begin the webinar. I really appreciate everybody logging on and joining us for today. We're very excited to talk about our accelerator focused on cardiovascular innovations called HeartX. Before we begin, what I first wanna do is inform everybody how to navigate through the webinar system today. So what you'll see at the bottom of your screen is a chat feature. And so today we are not going to use the chat specifically to communicate with each other, but in the chat, you will find the slides for today's presentation available. And they may come up a few times during the webinar today so that as other people are logging on, they would then have access to those. So you may see that posted a number of times throughout today's webinar. Also, we have the Q&A button at the bottom of the screen. And the Q&A button is how you're going to communicate with the presenters. And so we may take some questions as they come in, we may hold them until the end. We intend for today's webinar to be under 20 minutes, and then we'll be able to focus on Q&A for the remaining 10 minutes of the webinar. So this is how we're going to navigate today. Now, again, getting engaged with HeartX is our topic. And to do that today, we have two other presenters in addition to myself. I'm Joe Sassen. I'm the Chief Commercial Officer and Executive Vice President of MedAxiom Ventures. Thrilled that you're here joining us. Our webinar is on our accelerator, which was actually created three years ago in partnership with HealthTech Arkansas. And so MedAxiom and HealthTech Arkansas have created HeartX. And you're going to learn a lot more about that from Jeff Stinson. He's the Director of HealthTech Arkansas. So he's going to talk about our accelerator and what it does and why it's unique. I'll talk a little bit after that about how to get engaged specifically. And then Priya Bhargavi, who's the Clinical Trials Manager at HealthTech Arkansas, will also fill in what does it mean to pilot and what does that consist of if that's something that you would choose to do after learning more about this today. So to really get us going and to get us started here, I'm going to turn it over to Jeff Stinson. And Jeff, thanks for being here. Thanks for sharing. And I'll let you take it away. Excellent. Thank you, Joe. Appreciate that very much. And thanks everyone for giving us the opportunity to talk about HeartX. I think we can move to the next slide. So, you know, first question, the basics, what is HeartX? So many people have heard of an accelerator program. Some have not. But essentially an accelerator is just a program that puts resources behind startup companies to help accelerate their path to the market. So put yourself in the shoes of a medical device inventor or a company that started, created a new piece of software that would help in a clinical practice. Our program gets behind those companies and helps them get clinical engagement, therefore helping them to get their products in the marketplace faster. So we target digital health, connected medical devices and diagnostic platforms. Next, our claim to fame is that we think we're the only program in the country that guarantees hospital pilot projects for startups. That is a really big differentiating factor. Again, it is very difficult for startups to get into hospitals. Hospitals are complex, busy places with a lot of competing priorities. So it's virtually impossible for a startup to start cold calling and work their way into a hospital to get a chance to deploy their innovation to see if it makes a difference for patients and clinicians. So we have just created this program that guarantees that pathway. And because we're the only ones who do it, we just get really exceptionally accomplished companies every year. In fact, we think we're in a position now to say we're getting the world's strongest health tech, med tech startups around the world to apply to the HeartX program. So these are the seven largest cardiology practices in the state of Arkansas. This is where we started our program. And these folks have been with us all seven years of our program. We met Joe Sasson three years ago, and he helped us from our position of sort of toiling and somewhat semi-obscurity to putting us on the big map nationally. And now, so last year, if you'll go to the next slide, we had these seven cardiology practices from around the country who joined us as well. So sort of the purpose of this webinar is to expose the HeartX program to you so that any of the rest of you who want to join this program can have a chance to look at these new innovations and evaluate whether you want to do essentially a pilot project or a clinical trial with us. Next. So this is our small team. There are just eight of us on the Health Tech Arkansas team. You'll hear from Priya in just a bit. She will be instrumental in working with you if you choose to do a pilot project or a clinical trial with some of our companies. She'll be the one who kind of guide you through that process. So even for sites with not a whole lot of research experience, we really try to make this engagement with HeartX to be as easy as possible. But the point of this is there's a team behind you so you'll be well supported as you move through the process. So I'll just tell you a little bit about just the last two years to give you some flavor. We typically take four or five companies a year into our program. The last few years, we've gotten around 100 applications each year that apply to our program. Interestingly, when we first started, we were getting a greater number of applications, but they were of all stages and size. And some honestly were not prepared to step into a hospital and do a pilot project or a clinical trial. Now that we're in our seventh year of doing this, companies have sort of self-selected and we're just getting really strong companies. So the hundred applications that we get are really, really very strong. And so coming out of that each year, we pick four or five, actually you pick as hospitals, four or five companies that you wanna work with. And then we go about setting off to do those work. So these were the five companies in our 2022 cohort. These were the four companies in last year's cohort. And then I think we have a separate slide on a couple of different companies just so we can give you an example of sort of what these companies do. So in 2022, MediWell is a company based in Seoul, South Korea. They have technology that basically just takes a 30 second retinal scan, just a scan of a patient's eye and then processes that for 30 seconds, an additional 30 seconds through their AI software platform. And they have data to show that they can predict CBD risk equivalent to a cardiac CT scan. As you all know, the eye is the only place on the human body that has an open view of the vasculature of the body. And imaging has progressed now to where they can just identify CBD risk and they triage specifically into low, medium, high risk of CBD. And so this becomes the perfect community triage tool. So whether that's in a primary care practice that ends up driving better qualified patients into your cardiology practice, or whether that's sitting in the pharmacy at Walgreens or CVS or Walmart, just like a blood pressure scan, this is what we think is, this is the path of progress. We think this is the way that CBD diagnostics and screening will be done in the future. They entered our program. They got five hospitals who signed up to participate in their clinical trial because they're cleared in Asia and Europe, but not cleared yet in the US. So we just think it's a fantastic opportunity of something that's a pretty easy trial to participate in. And it's a program where we can be super helpful to a company like this. The next one is a company that was in last year's cohort called NanoWare. Really incredible technology. So you can see they've got 13 awarded patents and 12 pending patents so far, but essentially what they do is they embed technology, nanotechnology into cloth and apply machine learning remote diagnostics to remotely monitor and diagnose patients. So you can see there that the studies that they want to conduct with us, and we're in the process of connecting them now with hospitals and getting those studies up and going, is they want to diagnose right heart hemodynamic pressures that historically have only been done with an invasive right heart cath. So again, we're taking a technology that is non-invasive, cheap and easy, and applying that and replacing invasive measures in these clinical studies. So hopefully those are a couple of examples that sort of give you an idea of the types of companies that apply to the heart X program. Jeff, thanks for the great overview of the program and its genesis. I appreciate it. I want to spend just a moment talking about how this unfolds. What does this look like from two perspectives? Number one is the timeline, and then number two is what does it mean specifically as a participant? And so as Jeff said, we get about 100 applications a year and that application period just closed a couple of days ago. So we locked that part of our process and what our team is doing is really starting to pre-screen these companies. So after reviewing all of these, we will start to pre-screen, meet with these founders, meet with their teams, and really start to separate the wheat from the chaff just a little bit more. Of course, today we have a webinar informing everybody about the program, but what's really important is the next step. And this starts in just a few weeks, sometime mid to maybe even a little bit late May, we'll be doing secondary interviews. And that's at a point where we have already been through the applications, already met with founders and founding teams and help them to polish their pitch down to a five to seven minute pitch consisting of five to seven slides. And then we have an opportunity to engage with those that we think are the best of the best. And we have our practices and programs attend those interviews or those pitch sessions, if you will, to determine which ones that they, how would they rate them? Is this a novel technology? Is this valuable? Can we see using this in our program? And so there's a rating sheet that we have. And then all of that happens May 15th to July 1. And then after that, people say, hey, maybe I had fun evaluating them. That's great. Some people might say, there's some of these that we would like to maybe pilot inside of our organization. And at that point, we kind of move into our next phase, which is this July 15th to August 31st, where what we really wanna do is spend six weeks making sure we have alignment between the company, the study that they wanna run or the trial they wanna run, making sure that the PI from your organization is also engaged in that and making sure that we're all talking apples to apples and that there's a fit in order to actually execute a pilot with them. Now, you don't have to do any kind of pilot project, but if you do, we wanna make sure that everybody understands the scope. And then we will actually finally select those folks at the beginning of September and announce our cohort at the beginning of September. And then we do a big kickoff with them at the CVTrans Forum the day before Transform starts. And it's a great opportunity to come and meet some of these companies and be a part of that kickoff if you'd like as well. So this is the timeline. And obviously the most important thing in this timeline is we're gonna start interviewing these companies with programs in short order, and there's a way for you to get involved if you'd like. Now, what does this really mean in terms of the lift, right? And what's the commitment level? Well, as stated, we're looking at about 100 applications. The HARDx team, Jeff, Priya, others on Jeff's team, others on the MedAxiom team are reviewing these applications and then we will do those about 30, maybe 35 pre-screened interviews. And then we get to the point where it's appropriate for members to get involved. If anybody wants to be a part of 30 pre-screens, let me know, we're happy to put you on there. But what we're trying to do is make the best use of everybody's time and really bringing it down to 12. When we do those 12 pitches or those interviews, if you will, they're about 30 minutes each. That's it, about five, seven minutes, eight minutes on the pitch portion, and then another 20 minutes for questions. They go from 7 to 7.30 or 7.30 to 8 a.m. central time. They're all recorded. So if you miss one, that's okay. You can always catch the recording. And there's a shared scoring sheet that we use that everybody kind of ranks what they felt about each of these companies or rates what they felt about these companies. And that will be starting soon. That could be it for your involvement. However, if you would like to maybe pilot, then we start to work through that process that I described. We'll pair the company with you and your PI to understand if there are real opportunity for our program. And then we want those final commitments by the end of August. Then we will communicate back out about who, you know, based on pilot site availability, these are the folks that are able to get in. We do guarantee two pilot sites. The only way we can do that to our companies is guarantee two pilot sites is to have that commitment before we ever select them. Right? And that's why the selection happens so late in the process. So again, it's either you can be a part of 12 pitches and that's your full engagement and that's great, or you can decide to pilot something as well. So that's the high, high level. Now if you decide to pilot, and if that's something you would like to do, then we get into the clinical trials area. So I'm going to turn it to Priya Bhargavi to walk us through what that looks like and the support that HARD-X can provide. Thanks, Joe. So as Joe mentioned, from July 15th to August 31st, we'll do a sort of in-depth interview with the company and your site if you're interested to gauge feasibility and make sure that it's an appropriate match for everyone. So after that, if you do want to continue to participate with the company, then we'll start working to actually administer the trial or the pilot project. So that will include facilitating the study startup, we'll support you with any contracts, business agreements, IRB approvals, anything like that. One thing to note in this program, it is a no financial exchange program. So the companies aren't charged for the labor from the sites, and the sites are also not compensated in any way by the companies. That being said, we do not want our sites to take on any extra burden. So during that evaluation from July 15th to August 31st, we'll make sure that everyone's on the same page in terms of costs of the study as well. We'll also provide support with patient recruitment and any trainings that the sites might need. We have a lot of resources with our partners to make sure that our sites are trained properly if you don't already have a research division that kind of handles that part. We'll also address any issues that come up during the study. We'll help you and support you in every way that we can to make sure we have a successful trial and then we will support you with closeout with any questions that come up towards the end of studies as well. And as I said, we'll be there every step of the way and be able to help you with anything that comes up and answer any questions, anything like that. Thanks. Thanks, Priya. Appreciate it. I'd like to, again, direct everybody's attention to the bottom of their screens where you have the chat button and the Q&A button. And now is a great time to, you know, ask any questions that you have about the program. As we wait for some of those questions to come in, again, if you're interested in seeing some of these innovative pitches and seeing what's coming down the pike in cardiology, which may hit, you know, your awareness without HeartX in three to five years sometimes, then feel free to reach out to me and let me know that you're interested in being a part of these pitches and we'll just invite you to the pitches and invite you to the ranking spreadsheet. That's all it's going to take. After each pitch, of course, we will send out a link to the video that shows up as well. So I see some questions coming in now. The one that just came through just says, hi, Joe, with a comma, so I think there was more there. Oh, there we go. I'd like to be a part to see the pitches. Elizabeth, absolutely. Happy to make sure that you're included in that and we will get you invited 100%. Other questions, let's see here. Do I have to attend all 12 pitches? The answer is you don't need to attend them live. There's no commitment to doing all 12. It would be nice if you could do all 12, but you don't have to. What we see is that some people try to attend all of them and those that can't make it will watch the video and rate them from the video because, again, they're very short and they're actually very invigorating. Okay, so Q&A at the bottom, please feel free to submit. Is there a limit to the number of interested parties per concept? I don't know what that means. From the practice side, as many folks from your team as you would like can do that. Sometimes we see an administrator as well as a physician join as kind of a dyad relationship. Sometimes it's somebody in innovation who then says, I will bring this to my physicians because we're interested in this, or it's a physician that takes the lead, but from the program side, if you'd like to have a couple of people, two or three even, on, that's okay. Joe, it's possible that Kristen was referring to, is there a limit to the number of cardiology practices that could participate with any one company that comes through the program? And if that was the gist of the question, then generally, yes, there is a limit. Like if we had, for example, 10 hospitals who signed up to want to participate in someone's clinical study or to pilot an innovation, then that our cohort company would have to triage those or stage those or try to figure out how can we prioritize to do that. They're small companies, they're startups, they have limited bandwidth themselves. So MediWell came through in 2022, they had five hospitals that wanted to do that. We're not going to engage all five of those at one time. They will be staged as we get those sites up and going. Yeah. Thank you, Jeff. I think that's exactly right. That's what she was interested in. What is the timeframe for pitches or can you send the slide that has the timeline? So in the chat box, you can download all of these slides right now. And the answer on that is that we will be starting to bring some of those pitches out to the membership in mid to late May. So they're starting really soon. And we do those over a period of maybe six weeks or so, but you can download that exact slide with more detail from the chat box. Jeff, do you want to answer this? Yeah. So Kristen asking, how do we match make? Really good question. So essentially what we do is after we get through the process of let's say we pick 10 or 12 finalist companies and we go through those interviews and you all have had a chance to look at those companies. Essentially what we do is we poll our practices at the very end and say, who's interested in working with each company? And it really is a voluntary basis. So if your organization says we want to work on the MediWell study, we just record that vote and then we try to match MediWell up and include you as part of their clinical study or if you want to pilot a given innovation. So again, it's pretty easy. We just poll our participating sites at the end and get their feedback. And as Joe had mentioned before, if you see 10 or 12 companies and you don't want to work with any of them, that's fine too. There's no obligation. You just tell us the companies you want to work with and we'll go about the process of trying to make that happen. And I'll just add a little bit to that too. So in that third interview that we have mid-July to late August, what we try to do is get as much information from the companies as possible in terms of the kind of study that they would like to conduct. So you'll get all that information and you'll be able to do some feasibility on your end to make sure that you feel comfortable that you have the patient population for the study. So that's part of the matchmaking. We want to make sure that our sites and our companies are comfortable, that they'll be able to meet all the requirements for the trial and do the patient recruitment successfully. Thank you, Priya. So thank you, Kristen. I think that answers your question. If not, a follow-up would be appropriate. Let's see here. Please keep them coming. Please keep them coming. I've got another one here. Do you want to comment, Jeff, on the mix of software innovations versus medical device innovations? Yes. So that's a really good question. So over the past six years, we've had a total of 30 companies who have gone through this program with us. And it really is pretty evenly split between medical devices and software. And of course, you've got this Venn diagram where that's not a clear segmentation. Some, there's overlap there, right? And some innovations are combinations of software and device, like a remote patient monitoring technology, for example. But in general, we see about half devices and half software. We also see a pretty good balance of things that are pre-FDA clearance versus those that are post-clearance or never-needed clearance. So generally, each year, there's something in there for everyone in terms of balance and the types of things that interest people. Jeff, that's a great point about pre- and post-FDA clearance. And again, Q&A box is always open. But I want maybe Priya to build on that just a little bit to say, what does that mean from a clinical trials perspective, whether something is FDA cleared or not FDA cleared, just for the site's awareness at this point? Priya, you need to unmute. Yeah. Sorry about that. So anything that is FDA cleared, I'll give an example from last year's cohort. One of the companies, Smartcardia, is already FDA cleared. So their patch is on the market. And they are looking to learn more about their device. Things can be FDA cleared. But there's still other indications or other things a device can do. So that can kind of fall into two categories. Sometimes you do need to go through the whole FDA process. And then you have your IRB. And there's a good amount of paperwork that's involved with a clinical trial. With an FDA cleared device, that's not the case. Since it's already on the market, you don't have to do a lot of that formal paperwork. So where it's mostly just working out through your contracts and then going ahead and implementing the pilot project or the study with that company. So it's a lighter load for sites, especially that may be new to research. They may be more comfortable going that route first. Thank you, Priya. I've got a question here as well about if we do pilot, are they restricted from pursuing future investment possibilities? And the answer is no. I mean, there's no restriction of any kind. There's also, since the question was asked, there's no obligation to invest in anything. There's no prohibition from investing in anything. We're really trying to get the engagement and bring the technology to the marketplace more quickly. So yeah, there's no restrictions there in any way, shape, or form. Another question that's come across, how long will it take to complete the pitch feedback form? Typically, that's about two minutes a pitch, one to two minutes per pitch. And so there's categories and you just rate one to 10. So you have novel, you have one to 10, quality of the team, one to 10, how was the pitch received? Or do you think this product has value in your organization, one to 10? It's just a handful of questions that I don't think you could make it take more than two minutes if you tried. So great question. So we are coming up on time here. And I want to make sure that we end on time. Again, my email and Jeff's email are there on the screen. Feel free with any follow up questions. Let us know. There are a couple of folks, Elizabeth and Kim, I've got you down as you're interested. So we'll follow up. Anybody else, if you're interested in participating, please just shoot me an email, let us know and we will get you on the list. And that will put you on the mailing list, if you will, or the meeting invites. You'll get about a dozen of them over about a six week period. And then we'll also share the link to the scoring sheet so that we'll be able to do that after each session that we do, each pitch session. So I don't have anything else, Jeff, Priya, do you guys have any closing thoughts or comments? No, no, we just appreciate the opportunity and thanks for the interest in that people have in this. If you're the type of person or practice that likes new innovations and seeing the latest things come into market, this is a really good way to plug in and see those things. Priya? Thank you so much, everyone. Well, thanks, everybody. We really appreciate it. We encourage you to get engaged. It's very easy to get engaged and let me know if there's any questions I can answer for you one on one, or feel free to just send us your interest and we'll get you looped in. So thanks for the time today. Hope you have a great rest of your afternoon. Bye-bye.

HeartX

accelerator program

cardiovascular innovations

hospital pilot projects

startups

clinical trials