Medsider: Learn from Medtech and Healthtech Founders and CEOs - Demonstrating Value with Robust Clinical Trial Data: Interview with Miracor Medical CEO Olivier Delporte

Episode Date: August 1, 2022

In this episode of Medsider Radio, we sat down with Olivier Delporte, CEO of Miracor Medical.Olivier has more than 20 years of sales, marketing, and general management experience, mostly in the medical device industry. In 2016, he became the CEO of Miracor Medical, a medical device company based in Belgium. Under Olivier’s guidance, the company is advancing its flagship PiCSO treatment for severe myocardial infarction.  In this discussion, Olivier explains why he advocates for randomized clinical trials, how remote monitoring tools can make clinical trial programs more efficient, and why startups should increase their fundraising goals.  Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Olivier if you'd rather read it instead.

The fix of therapy is transformational and the health economic value proposition warrants a premium price, which is not included today in the DRGs for the stenting procedure. And we don't want it to be there because we want to make sure that the value is recognized and reflects the health economic value proposition. So we have really embarked into working prospectively on creating codes, creating coverage and over time getting the right to months payment for therapy. Welcome to MedSider Radio, where you can learn from proven medtech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson.

Hey, everyone, it's Scott. In this episode of Medsider, I sat down with Olivier Del Porte, who has more than 20 years of sales, marketing, and general management experience, mostly in the medical device space. In 2016, he became the CEO of Miracor Medical, a Mediotech. company based in Belgium. Under all of years guidance, Miracor is advancing its flagship pixotech treatment for severe myocardial infarction. Here for you the key learnings that we discussed in this conversation. First, keep collecting data even after you get regulatory approval. Generating strong clinical evidence through randomized trials substantiates the value of

your technology to patients, doctors, and payers even after you hit the market. Second, Miracor Medical takes advantage of remote monitoring tools to make its clinical trials more efficient and cost-effective. Consider going virtual using high-end surgical monitoring platforms like Avail or Explorer Surgical. You can also use more common video conferencing systems for less complicated procedures. Third, focus on long-term fundraising goals and aim to raise more money than you think you need. You want to be prepared should you encounter development delays or challenges down the road. Okay, so before we jump into the discussion, I wanted to let you know that we just released the first volume of MedSider mentors, a print-based book that summarizes the key learning.

for my favorite Medsider interviews over the past six months. Look, I fully realize it's tough to listen or read every Medsider interview that comes out. Even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Gar Hong Kong, founder of HealthQuest Capital, teaches you how to successfully pitch your startup.

Patricia Ziliak, CEO of Ivansons, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to medsiderrady.com forward slash mentors. If you're a premium medsider member, you'll get free digital access and a print version sent straight to your door. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of LiveCore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors.

Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. All right, Olivier, thanks for coming on Medsider. Hopefully I pronounce your first name correctly. You do. Thanks, Scott. Thanks for inviting me. Yeah, looking forward to the conversation. I know we chatted about this a little bit beforehand, but one of my boys is named Oliver. So it's just, it's natural for me to say Oliver, you know, which I think, you know, Americans would pronounce maybe your name that way.

But in France, it's maybe, maybe you, maybe is it Olivier, right? Is that the- Yeah, Olivier, though I was born in the US, but more European than American. But yeah, Olivier. Or you can pronounce it. Very good. Latasa, I'm looking forward to the conversation and learning a little bit more about your background and then what you're building at Miracor. But with that said, let's start out with that.

Without going into, you know, too far into the weeds, tell us a little bit more about what you were doing leading up to taking on the CEO role at Miracor. Yep, thanks, Scott. So after an MBA at the University of Chicago, I actually started with guidance as many mettech people. Guidant was a great school, started in pure sales in endovascular. So I sold carotid stents, SFA stents, renal stents for a couple of months. And then I had the chance to move over to marketing into interventional cardiology. So still on the stand side and managed a couple of projects.

And in the end, launched drug alluding stents for guidance, which had become abode vascular after the purchase and split with and between Boston and Abbott. but I had always been tempted by ventures, entrepreneurial, you know, companies. And I moved over from the large companies to a small one, and I joined a very small company then called Triton Medical, basically an interventional cardiology coronary barrication stent company, which was supported and funded, among others, by BTV and Rick Anderson. And we launched the product. We ran an IDE study. that company was not sold for actually interesting reasons, good learning reasons.

And in 2013, I moved from that company to interventional criminology and was with a company called Numerix Bay Area-based Coral's company for emphysema patients, similar to what Plymonex is doing today in the space. That company was commercial and was sold to BTG. and after integrating numerics into BTG, it lasted a good year. Then I was recruited at Miracle, and that's indeed 2016. Got it. And you're just kind of going back to your early days at guidance, you know, after your MBA at Booth, right? Was it? Is that where your MBA is at?

Yep, that's correct. Was that, did you move over to Europe, you know, immediately? Or was that time here in the U.S.? Yeah, great question. Actually, was fired in Europe. from the get-go. So I finished my MBA and interviewed with the guidance Europe team. My family had been based in Belgium and guidance was headquartered in Belgium at the time. So I started in pure sales in the Belgian sales organization and then moved over to the Europe, Middle East Africa headquarters,

which was based there. Okay. Got it. Got it. Makes sense. All right. So, you know, kind of back into the 2016-17 timeframe, you joined Miracor. Tell us a little bit more about, is it, is it, Is it the Pixo system? Am I pronouncing that correctly? Tell us a little bit about what it is and kind of how the idea came to be. Yeah. So the PXO system, indeed it is PIXO. Okay.

And PXO stands for pressure-controlled intermittent coronary sinus occlusion. So what's important there is the coronary sinus part, which is the venous part of the heart, you know, the occlusion part. And it's basically a mini-invasive approach to occluding the coronary sinus, which, of course, drains a good part of the blood flow from the heart. And so the pixel concept comes from cardiac surgery, where, you know, starting in the years 50 with the best procedure, you know, cardiac surgeons had been retroperfusing venous blood through the coronary sinus, and there were different applications like cardioplegia, retroperfusion. And what happened over time

is that, or the miracle founder, who is a professor of cardiac surgery from Vienna in Austria, you know, worked on animals and he developed a mini-invasive weight to occlude the coronary sinus as he had observed, you know, the beneficial effects in patients, but it had to be worked on, treated a number of animals, and part-size reductions, and really led to the inception of the company in 2008. And then what happened is they had worked mostly on, XO. So there wasn't the P. The P stands for pressure control because they did not have the technology for that. But then what the company did, once Miracor was inceptive, is on the base of technology really made the therapy move from XO to PXO, adding the P, which is the pressure

control, thanks to the technology. And it really made the therapy become safe, automatic, patient-specific, reproducible. And that's where we are today. It's on the base of technology and software and the learning from the past that the therapy is what it is today. Got it. And so give us a sense for the timeline. When did the company make this pivot to incorporating the pressure element? Was that prior to you joining? It was prior to me joining. So that really happens between 2008 and 2011, 2012. And then there were the first series of patients treated, the very first. clinical studies, I would say, and I joined in 2016 when, yeah, there was already, the product was existent. We changed an updated product, but the product existed already yet, you know,

with work on the next generation one since then. Okay, okay, got it. And I know that the folks listening to this can't see the very cool looking system that I can see in your background here on Zoom. But I'm assuming when you joined in 2016, it's, didn't look nearly as finished as the system that I'm seeing here. So is that the case? You know, I guess what generation are you on now? And tell us a little bit more about sort of where the company's at from a lifecycle perspective. Yeah. So from a look standpoint, it actually looked pretty similar. I mean, this one is a little bit slicker, though I envision, you know, we're in the world of technology and iPad. So I'd love it to be an iPad, kind of

but that's a few years out. So the company is really, you know, at the stage of, first, let me talk about the unmet need or the patients for targeting. We're really addressing acute infarct patients. So that is our patient group or patient beach head. The largest or highest risk patients of these acute infarct patients are ST elevation and my patients.

So patients who, if they're not treated, they will die. Those are the ones we address with, or PIXO system. With PIXO, we really aim at improving the micro-circulation of these patients. We have treated by now 320 patients where 32 full-time equivalence, so employees or full-time consultants in the company. And we have C-Mark in Europe, breakthrough designation in the U.S. from the FDA. And we expect actually the approval from the FDA for our IDE study in the coming month. So that's from a regular lottery standpoint where we stand. And from a where are we looking, where are we going towards, you know, while we have C-Mark, our focus is on generating strong

clinical evidence. So we're not in a that you C-MARC and go all out. We are putting most of our efforts and most of our focus on clinical evidence. So we have a currently almost finished randomized study in Europe for anterior stemming, and that will lead to the start of our IDE study in the U.S. in a couple of quarters, and then we started a second randomized study and a second indication inferior STEMI a couple of months back. And commercially, you know, we use our C-Mart, but very selectively to generate awareness, to support reimbursement, to develop training tools as well and improve tools. But it's not a go-all-all-all-off. at sales and revenue as it could have been, you know, 10, 15 years ago in the Mettech world.

Got it. Yeah. I think, well, that's definitely something I want to circle back around to get your kind of your thoughts on how that shifted, right? And I'm sure that's very intentional, you know, as you're leading the company forward. But before we get into some of those more specific questions, help me understand kind of like what, from a patient physician standpoint. Like, what if I'm suffering from, you know, an MI and a physician doesn't have access to the Miracore technology, what are they using now? How are they treating? Yeah. So there is no predicate.

So today when an ST elevation in my patients, you know, feels chest pain, calls 911, is brought to a hospital typically and hopefully for the patient, he or she is brought to the cat lab. And there is, you know, cat lab service in that hospital. and then the interventional cardiologist will perform an emergency stenting procedure to unclog the artery, which is blocked. If you think about it, the stem-y-patient population is one of the only state, I would say patient populations where you save a life in interventional cardiology because you save it instantly. The chances of that patient dying if the patient is not stented are very, very high. And so today, the state of the art is a PCI, which is the angriplasty procedure whereby a stent will be implanted in that occluded artery to open it up and leave it open. And what the pixel aims at doing and has been shown to do in studies today is to reduce the infarct size.

And the infarct size is basically the quantity of the left ventricle. It's the mass of the left ventricle, which is necrosed or dead a couple of days or a couple of weeks or months after the acute infarct. And that is basically the highest risk patients will have up to a third of their left ventricle, which is dead after the large infarct. And what PXO does is reducing the infarct size, which should translate into less mortality and less heart failure hospitalization. So there's a very strong link between infarct size and these two clinical endpoints that matter. Got it. That's super helpful. Okay, very good.

With that said, Olivier, you just mentioned a few of the milestones you've been able to achieve so far, right? CE mark, I think in 2020, breakthrough device designation from FDA. When you think about the past, you know, four or five years kind of working your way through some of these, you know, challenging regulatory waters, you know, what are some of the key lessons that you've learned along the way? And that may be helpful for other med tech entrepreneurs that are kind of waiting in that in that same boat. Yeah.

So I would say work with people who have done it, you know, and regular people are, regularity people are well sought after these days and there are a number of employees and consultants, but you need people who have done it. It makes such a difference to get into the offices of the FDA and have your lead regulatory person now half of the people in the room because here, she have interacted with them in the past. And I think that's important. The other advice would be talk to these regulatory agencies,

talk to these regulatory bodies. Certainly in the case of FDA, you'll hear them publicly say, talk to us. Call us, meet us, plan a pre-submeeting. And I think certainly in the case of the FDA, the agency has become very collaborative over the years. So do not hesitate. Talk, email, because that helps. Yeah, those would be my major advice is on the regulatory front.

Yeah, and it sounds like, you know, your kind of your first message is around working with people that have done it before. How important do you think it is to work with, you know, regulatory, you know, consultants or agencies that have domain expertise in this clinical area that you're working on? Yeah. I think it helps. You know, it's always the same when you, when you recruit recruitment, a recruitment is actually very difficult these days in MetTech on both sides of the ocean, right?

but I think it helps depending on the specificity of what I would call the vertical, you know, we are in interventional cardiology. Depending on the specificity, it's anywhere between a nice to have to a must have in recruitment because every space is different. You know, I've done most of my career in interventional cardiology, but I'm also involved a little bit in the gastroenterology space, a little bit in neuro and other stuff. It's different.

And so having people who have been in the cardiovascular franchise, you know, and working in that vertical, I think helps significantly. But it's not a must for every vertical. Got it. Got it. I love that. I love friending it around that kind of that nice to have, but not, not 100% critical, right? As an example, you know, someone with, someone with, you know, deep experience in regulatory that may not have as much, you know, experience in the interventional cardiology space. they could still be a valued, you know, a valued partner. Yes. And, you know, I also think, you know, diversity and diversity of prior experiences is a big plus.

Yeah. You know, it helps people because things are done differently in different verticals, go back to that term. And I think the experience of, you know, regulatory executives can be a big asset as well. Got it. Got it. Yeah, that's super helpful. Let's kind of use that as a segue into something you mentioned earlier, right? and your focus on really building out clinical evidence.

And I think if my notes are correct, you're currently enrolling patients in your second randomized study. Is that right? Yep. Yep. Okay. You mentioned kind of this sort of this shift where, you know, 10 years ago in MedTac, once you had regulatory, you know,

clearance or approval, it was sort of game on from a commercial standpoint. You know, now, you know, you're running Miracor and you definitely have a different strategic sort of perspective on that. So tell us a little bit more about. that and how you're just your general thoughts around around you know building out a clinical roadmap. Yeah. So I think the need for clinical evidence and strong clinical evidence has definitely increased over the years. And there are differences across the methic verticals, but certainly in cardiovascular, you know, interventional cardiology, structural heart and all the

related today randomized trials are the name of the game. And indeed, anecdote is that when I started with Miracor and my pre-approval discussions with the board, they had not done a randomized trial before, but I was strongly in favor and actually saying, you know, I'll join, but we have to do a randomized trial because I really believe it's needed. And in today's world, in interventional cardiology without randomized evidence, you won't get to guidelines, which means you won't get to reimbursement. So I think, yeah, those days of 10, 15 years, are gone. And today we have decided basically to build our fundamentals on strong evidence, especially because it's a big unmet need, you know, the acute infarct, but it's also an unmet

need where there have been a couple of attempts over the last decades, which have failed, which is why the standard of care today is still stenting. I mean, stenting has held these patients, but at the cost of heart failure hospitalization. So basically, the stemmy patients less because they are saved by the stent, but they leave the hospital with part of their left ventricle, which is necros, and over time, they develop heart failure. So the goal is really to decrease the infarct size to have less heart failure in these patients. And so we've decided to generate data. And we're doing that, you know, in a start with the highest risk patients and we'll expand over time.

So right now, the first randomized study that we started before COVID, is in interior ST elevation in my patients and Timi 01. So the most high risk, a bit like what Edwards and Metronic have done in Tavi, which I often refer to. The model is beautiful. That's, you know, the poster child of market development. Start with highest risk and expand over time on the base of evidence. So we've started with anterior stemming Timmy 01.

And that study in Europe is about too close, actually, enrollment in a few months. So we're almost involved. we expect completion of enrollment by September. And that's going to be the segue also to starting a very similar study in the U.S. Well, for the FDA, the patients will be enrolled in U.S., Canada, and in most likely Europe as well. And so with that same optic of building evidence per patient group, last year, the first in man experience in the next patient group, the inferior

ST elevation and my patients was published, it was positive. It was the first in May, so nine patients compared to 18 controlled patients, and it was very positive. So on the base of that, we've started for a second randomized trial in that patient group, in Europe as well, on an observational basis, because we didn't have enough really to have stats. And based on what we learn in that randomized study, then we will decide, you know, where to go regular lottery-wise for indications. And we might think of, you know, asking the FDA for another

arm in the ID study, for example, or having a parallel study. That's, that, you know, we'll see that with the results when they come. Got it. Got it. And so, and just to kind of help baseline for anyone listening is really just as well as myself, you did first in man in Europe, correct? Correct. Nine patients. And then your first RCT was in Europe as well, where all the sites in Europe? The first RCT, yes, is done in Europe. Currently in most of the same sites as the first randomized study. So the PXOMI1 study is finishing in Interior Stemi, and we have started the PXO Infair, the PXOMI5, inferior STEMI in a good portion of the same sites, which have experience, and it will be done in Europe. But the purpose then is to move to the U.S. based on the learnings for

that one as we are doing with the anterior stemming patient population. Got it, got it. And that U.S. RCT, will that serve as your pivotal then? So the U.S. IDE study currently as it's discussed with the agency is a study for anterior stemming. Got it, got it. Okay. Okay. First patient indication. Makes sense. So you definitely have a lot of clinical activity going on. There's no doubt about that. And it sounds like it's really well, really well thought out. I think most people, including myself, would probably hear this activity and say, wow, Olivier, that sounds expensive, right? That's, you know, you're having to allocate a lot of budget towards this. Do you have any thoughts

around how to, I mean, everyone knows sort of like clinical trials are expensive, right? But do you have any thoughts around, or like, how are you thinking about trying to maximize the efficiencies across all of these clinical initiatives? Yes. In our case, it's actually one of the reasons why we did we started the inferior semi-randomized trial in Europe and in the same sides because it was synergistic and efficient especially because our patient population is a difficult one because they come 24-7 so to start a site it takes basically standby it's like stroke patients you don't know when they're going to come and when they come it's really a matter of minutes so we've been synergistic with that yet over time you know we want to be synergistic

in the U.S. I will tell you the one thing that is helping us and starting to help us significantly is remote procturing. You know, COVID has put the spotlines on distance learning, of course, Zoom and teams-based communications. Well, for communicating with the CAPLAB, you know, recently, we have seen an exponential use of our remote procturing solution, and we have proctured, We, I mean, our clinical specialists have proctor procedures in some hospitals while they were on the highway just pulled over in a parking because the hospital called them saying, can you support a procedure via your laptop? Or clinical specialist supported it from the car. Another time, the person was in an airport, and of course it can be done from home and from anywhere. So that's helping for the learning curve, which fortunately for PIXO, because it's a fairly simple,

technology is not many, many procedures, but it's a couple of procedures. The complexity for us is that the patients come 24-7 unannounced. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium Members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of Cala Health, Nadim Yared, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical device and health technology entrepreneurs.

In addition, you'll get a copy of every volume of Medsider mentors at no additional cost. To learn more, head over to MedsiderRadio.com forward slash premium. Again, that's Medsiderradio.com forward slash premium.