How Do You Move a Pediatric Heart Device Toward Trials?

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0:00 Many years later, it would be proven by the four rounds of preclinical trials and you know, heading very quickly into one final clinical trial. We've survived COVID, we've supplied survived supply chain shortages, and we've gotten to the point I would always wanted a business that was closer to my personal beliefs and my personal spiritual beliefs than just making money. It's so exciting. I can't even you know, I can't even give you words for it when you see when you see this happen. Unfortunately, a lot of these patients just die.

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Terry Coutsolioutsos. Let's remove some friction. Welcome, Zero Friction Podcast nation. I have an exciting day today and a wonderful guest, Seth Bogner, who's the chairman and CEO of HeartPoint Global, which is a company that manufactures a very unique product called the IntelliStent. The company's developing a patent system of stats that will control blood flow and has the opportunity to make a huge impact not only on pediatric patients, but also patients with heart failure. Seth's journey and the HeartPoint Global was sort of a a journey as first he came from finance and then he invested in the company and then over time his journey took him to be the chairman and CEO. And with that, I'll turn the story back over to Seth and and let us know a little bit about himself personally, professionally, and tell us a little bit about the company. So, Seth, welcome.

Oh, thanks, Terry, and thanks so much for having me. I really appreciate the the fact that you are in this space and you know, really understand exactly what we're doing. So, thank you so much. You know, HeartPoint has been sort of a labor of love {slash} legacy for us. We We're everybody in the company is totally mission-driven, and our everybody wants to help the 90% of the kids globally who don't have access to cardiovascular treatment, as well as you kids in the United States and Europe who don't have access to minimally invasive solutions that will improve their quality of life either while they're waiting for an organ, or eventually maybe even a destination technology. So, I came to this as as Terry said, uh as you said, as an investor. I thought that that the idea was fascinating. We'd done some research.

2:44 We've hired consultants. We did the the most thorough kind of due diligence you could do to see if this would actually work. And we believed it would. Now, many years later, uh we've been proven by, you know, four rounds of preclinical trials, and you know, heading very quickly into one final clinical trial to sort of tie all the information together, and then first-in-human, which we expect to do before the end of the year. So, we're now at that very interesting time where we have, you know, everyone always says to do a device takes, you know, 10 years. And that's true, by the way. But, we have gone through all the fits and starts.

Uh we've survived COVID. We've survived the survived supply chain shortages. And we've gotten to the point where we have a lot of exciting things happening in a very short period of time. Over the next less than a year. We're sort of poised, ready to go. Team and I are are working super, super hard right now. That's awesome. So, so tell us a little bit as about the journey. Like, you I know that you and I had had a previous discussion just, you know, starting and stopping with COVID and then having operations in Ireland and moving to Israel and all sorts of this sort of, you know, changes and transformation and then along the way kicking up a few awards and grants with, you know, a phenomenal concept and technology as well, right?

We're very We we started the company in Ireland. I was living in in Europe at the time as well. Really was we thought this was a great place to develop the device and it was for a lot of reasons. We ran a full team out of Ireland until COVID. Once COVID hit, we figured that we'd probably be best off in Israel, even though we weren't really in the ecosystem there, which is why most companies are there, because we own the intellectual property. And under the Israeli system, you your intellectual property needs to be based in Israel, so they can could collect taxes off. COVID, you know, really we we we were running a uh trial when COVID broke. When you're running a chronic trial and you're worried about who's going to go feed the sheep, it's pretty scary, but the results were amazing and we were able to do it and I was able to get in and out of Israel during during COVID. I'd taken over the company shortly before because I didn't think

That things were moving fast enough. I was the best CEO the company could find it for me personally, who's somebody who's worked in finance and financial technologies, restructurings, fund management. This was a sort of legacy kind of thing. I had always wanted a business that was closer to my personal beliefs or my personal spiritual beliefs than just making money for the sake of making money. So, I came to this sort of later in life. Learned a lot. Very fortunate that you know, my son is in is was in the in the cardio cardio area and a lot of smart people. I I hired a lot of smart people who taught me as well.

5:50 And you know, you talk about the awards we we won, both pediatric and adult, you know, we we won the you know, going back to the 23, the Shark Tank Shark Tank Innovation competition from the cardio cardiovascular research foundation. We won an award from the European Innovation Council. We won various pediatric device consortiums and I think most importantly late last year won uh National Institute of Health's SBIR straight to phase two grant, which allowed us to continue with our developing our technology for children and prepare for clinical trials. And we're very grateful to, you know, people are saying that so many things have been hurt by the NIH. We're we're we're very grateful to be to say we've been helped by the NIH. We hit a lot of, you know, we're we're we're dealing with chronic disease, we're dealing with kids, we're dealing with all their sweet spots that they have really taken taken focus of. We are moving ahead, you know, moving very very quickly, about to do another pre-submission to the FDA, very

Full menu of testing that we're going through, we're manufacturing design freeze, heading towards first in humans quick as as quick as we can, but we're doing everything in the United States, which is where we ended up. Things do work better here than they do in other parts of the world. It is more efficient here. It might be more expensive on some levels, but when people talk to me about doing first in human OUS, it does sound pretty attractive on some levels, but we've been able to get the support of just one example, which is a great example, of something called the Action Network, which is every pediatric heart failure specialist in the country, 750 of them. And they've been extremely helpful in terms of advice. And they they I believe they'll they will be extremely helpful in terms of sites and patients. And you know, they want to cooperate with us on our EFS and and first in human. Well, leads me to my next question. This like let's talk about the problems that

The technology is trying to solve. And I know pediatrics is number one. And so we look at therapeutically for what problem number one are you trying to solve in pediatric patients? And number two, what are those options today without an IntelliStent? Well, you know, I guess lead the lead indication is left LV DCM, left ventricular dilated cardiomyopathy, which is for very sick kids. Kids that are in need of a transplant, kids that are in in in need of stabilization. And what we what the technology does, I can actually show you a video or upload a video, you could sort of splice it here if you want, is we are strengthening the RV and actually there you could see and we've soon seen this in preclinical, a septum shift. So the balance between the left heart and the right heart is reformatted in a way that the heart could function normally. And this is done in a way that is reversible, adjustable, and this is the most

9:08 Important point. Because when people were doing or and I still are doing banding, they are taking a band, forget what it's made of, and tying it around the pulmonary artery. The shock alone of this tightening could kill the patient. And our methodology is much different. What we do is we slowly, by putting first device in, the first stent in, and then we could put another stent in if more flow and pressure needs to be reduced in order to get the effect and you see the effect almost immediately on the screen as they're doing the procedure. It's so exciting. I can't even, you know, I I I can't even give you words for it uh when you see when you see this happen. So, what we discovered is that this tight reduction of flow and pressure is not necessary.

That the effect takes place at levels much lower than previously thought. Now, if you go ahead and you're doing banding, you have to come back if you if you don't have the pressure and flow right, which they don't get most of the time the first time as I said it when we talked earlier, you have a 20 per plus mortality and morbidity rate in in this procedure. If you don't get it right the first time, you got to go through it a second time. You got to go ahead and and and crack the ribs open do an open chest procedure. And that open chest procedure once again has another 20 plus percent mortality and morbidity rate associated with it. Or you're putting the kid on a VAD and there've been a lot of problems with pediatric VADs in the United States or globally, I should say. Uh which ties the child to the hospital. And of course there's ECMO, you know, but unfortunately, a lot of these patients just die. Uh

Here we have a way where under light anesthesia, we can go ahead, do the intervention, make whatever adjustments are necessary. By the way, if the patient's condition changes or the patient grows, we could ablate the device so it goes back to where it was or incrementally go up. So, we we could do this in the same minimally invasive way. A day, a week, a month, a year later, anytime. So, this makes it even more exciting that, you know, as the conditions change and we can adjust to those conditions. And that's what's truly unique about this. It's It's not a question of, you know, one and done.

11:39 It's a question of we will adapt the device to the patient. And every patient is different. And you're dealing same thing is By the way, the placement's the same for most of the cardiac placements, which is either in the main pulmonary artery or in the branches. FDA has suggested that maybe we'll do in a multi-arm trial, and we're talking to them about that right now. You know, we could go ahead and do a pulmonary hypertension caused by congenital heart disease. We can also uh pre-Eisenmenger's patients. We can also do single ventricle some single ventricle patients. Do you want to show the video? Do you want to pull the video in right now? Or Or Sure. Sure. Okay. There you go. I'm going to share the audio as well.

Okay. And this is going to take This is going to take take us through the dilated cardiomyopathy and pulmonary hypertension. We'll take us through both indications. And it's only a couple of minutes. Pressure. We are proud to present to you the HeartPoint Global Proprietary Delivery System, also our new HPG stent implants. We use our system to treat cardiovascular diseases in a minimally invasive way, preventing the need or acting as a bridge to heart transplants, artificial hearts, and other surgical heart procedures. The HPGS is fully reversible, works well with other therapies, and is adjustable at any time after the initial intervention. In a left ventricular dilated cardiomyopathy, the left ventricle enlarges. Next, the interventricular septum shifts to the right side of the heart. Left untreated, this usually results in heart failure or death. The delivery system is introduced into the femoral vein. It then travels up towards the heart and through the inferior vena cava. It enters the right atrium, the right ventricle, and then the main pulmonary artery. The stent can

Be placed in the MPA or in the right and left PA. In this example, we deploy implants in the left PA. This patient, the flow is still too high, so we put a second implant in. Now, the flow is perfect. The same placement procedure applies to the right PA. The intervention is now complete. After our stents are implanted, the left ventricle and the IVS return to normal. The patient's condition improves. In the case of a ventricular septal defect, oxygenated blood enters the right ventricle, and the blood pressure becomes abnormally high. Too much blood flows into the lungs. At this stage, surgical or interventional closure of the VSD is a high-risk procedure. Left untreated, the pulmonary vessels become so badly diseased that less and less blood filters through the lungs. This causes a severe lack of oxygen, and the patient's condition deteriorates. Once the HPGs is implanted, blood pressure and flow towards the lungs are regulated, allowing the pulmonary vessels to recover. After our procedure, the patient is stabilized and is ready

14:42 For further treatment or surgery, if necessary. The HeartPoint Global System is both groundbreaking and disruptive because of its low cost, increased safety for patients, and its unique adjustability. The system treats not only these indications, but many others in a safe, easy-to-use, cost-effective way that significantly improves both the patient's condition and quality of life. Team at HeartPoint Global thanks you for watching. Wow. Now you've Now you've seen the full video of that one. We have other videos What a an amazing technology. And, you know, I'll I'll kind of date myself a little bit, but, you know, I sold some of the first self-expanding stents ever in the marketplace with the Wallstent.

And you know, so I'm very familiar with coaxial and biaxial, triaxial delivery system, as well as, you know, some of the nitinol products when I worked at Abbott. So, very, very familiar with delivery systems, the metal, you know, first of all, you're treating something that is challenging to treat otherwise. And then number two, kudos to you for building, you know, a delivery system that physicians are probably used to using, which makes it even, you know, more acceptable from a technology perspective. Yeah, you know, there's always a question of what what the clinical buy-in is.

You know, and it's that the UI and the UX, that whole user experience is important, especially when it comes to precision delivery and, you know, not having stents sort of jump and move around because of energy transfer and, you know, all that stuff is a really important element. Well, this was this was a big issue, you know, because a lot of people said that maybe we couldn't deliver in the main pulmonary artery because of the velocity of flow and pressure that's in there. And we proved that we can. Depending on the patient, depending on what the clinician wants to do, you could either place in the main PA or in the branches.

So, and we we've stress test both. We we we we haven't had movement. The question always comes up, was there any thrombosis? There was no thrombosis. Just really amazing what we've learned and what we've been able to prove so far and what we'll be confirming in the next couple of months. That's awesome. So, your first step into the marketplace is around left ventricular dilated cardiomyopathy in the pediatric world, correct? Is that kind of the Yeah. Yeah. the entry space and then and then you're going to leverage the platform and you expand it out into other indications later. Is that sort of the game plan?

17:13 We chose left ventricular dilated cardiomyopathy cuz it's an unmet need. That's what resonated but most with the clinicians as we discussed it with the community. We we sort of foresee one indication per year rolling out after that. You know, we don't know how the FDA is going to view whether we'll be able to 510k or whether it's going to be a you know, abbreviated PMA for each indication. I think when you go to different parts of the body or you go to something cardio sinus, it it's probably going to be not a 510k. So, but the good thing is is that for the early indications, we don't have to prove the science. The science is there.

So, you know, we're we're anticipating that, you know, what we're doing now, we're going to do first. We're doing it for kids through adolescence. We're working on right now infants and neonates, which is a slightly different device. The technology is the same, but the device is different because the needs of the patient group are different. We'll we'll we'll go on from there. But, you know, as Elena mean who's our chief medical officer who's an attending professor at University of California, San Francisco, she, you know, said, you know, I had this patient today and I could have really used our device. You know, with speaking to other interventional cardiologists around the world, I hear the same thing. So, how it rolls out, we'll see. You know, we we right now all of our focus and effort is getting that first, you know, IDE so we could so we could move forward.

That's really exciting. So, what do you you know, what's what's next in terms of the pathway? So, you you you have a device, probably have some safety trials that you've got to sort of play out and then and then, you know, begin the regulatory process. Do you do you know what is that game plan here in the US or are you going to go globally or what's what's sort of the regulatory pathway for you? We we we we think we're good we think we're going to go US. And the reason we're going US is I think we have the best system in the world through the FDA. When you get approval in the US, you get a lot of other approvals at the same time. So, if I get the US, I also get Brazil.

You know, which is a huge market where we potentially will be a destination therapy. So, and it's a huge market. I can't tell you doctors that have come and talked to me and said, "Why can't you get this to us quicker in places like Indonesia, Malaysia, huge huge markets. But, I think sticking close to home and getting everything done here, you know, there's a certain quality issue. I think we'll very quickly go for MDR in in in Europe and we're working on you know, that that path and we're making sure everything we're doing will qualify for both. But, I I just think that the support that we're getting for pediatric device in the United States by the FDA, by the NIH is is is recognizing something that's been skipped over for a long long time and not really gotten proper attention paid to it for a long long time. And we want to really fulfill those unmet needs first before we go before we branch out.

20:30 That's amazing, you know, cuz the missions missions clear. You know, a lot of you know, a lot of investments aren't made in the pediatric market just because a size perspective is typically not the biggest markets you can have. And so, kudos to you and your team for focusing on pediatrics, making it happen quickly, developing the right regulatory pathway so that you know, you can move efficiently through the process. So, I don't I think it's amazing what you're doing. Thank you. You know, people always say that it's not a big market, but you know, if if you start looking at things from not just pediatric LVCM, but LVCM is a big indication with, you know, recognized recognized population of over a million patients. It's pretty big. Then you go to some of these smaller things like C H P H D. It's still over a you know, 150,000 patients. And I'm not talking about even you know, what happens much later because you could see down the road that we could be talking about

Things like adult heart failure, like heffref, you know, refractory angina. There there a lot of different ways, you know, this this this could play out. But the amount of effort, focus, money that needs to go into just that first idea is enormous and we continue to learn a lot as we move through this process and and and the news is all good and that's that's that's the headline and uh you know, but I think dotting our eyes and crossing our Ts with the help of the regulators is very important.

Absolutely. Well, Seth, I'll kind of close it up right now and I'll just say thank you so much for sharing your personal story, the mission, you know, the story behind IntelliStent and and what HeartPoint Global is looking to do. So, wonderful, purposeful, mission based. Thank you for your time today. Thank you for sharing and we wish you the very very best in the future. Thank you, Terry. I look forward to hearing from you and maybe working on some stuff together. Absolutely. Okay. Thank you, Seth. Okay. Ciao. Thank you.

That's a wrap on Zero Friction, the show built around one simple idea. Remove the barriers and the revenue will follow. If today's conversation was valuable, please subscribe and share it with somebody who needs to hear it. That's how we will grow this community. I'm Terry Coutsolioutsos, a revenue architect powered by AI. Come find me at my website, myrevRX.com and let's talk about what friction is costing you and your organization. Until next time, keep removing the barriers and keep the revenue flowing.