The DiGAs Framework, and the Evolution of Getting Healthtech to Market in Europe | LSI Europe '24

Amine Benmoussa 00:00
I'm glad everybody's able to stay with us for a little bit longer. We're going to be talking about the DIGA Digital Health Applications Framework and the evolution of getting health tech to market in Europe. With us today to talk about this is Amine Benmoussa, who is a partner at Karista. And please pronounce and correct me if I mispronounce the company name, Samantha. Samantha, you? She is a partner at Elaia Partners, and Martin Mueller, the senior investment manager at CARMA FUND Management, and Laurent Pacheco, the venture partner at Solas BioVentures. I'm really excited to have you all with us to talk about this framework. This is an interesting pathway to market for a digital health application. But maybe Martin, you could explain a little bit about what this is and a little bit of the background behind the DIGA. Sure.

Martin Mueller 00:55
Yeah. So just to give an overview, so we are on the same page here. DIGA is a reimbursement system for digital therapeutics in Germany. It means digital Gesundheit and, well, there is a very nice German word that translates to digital health apps. It was enacted a couple of years back, and it kind of introduced a system where, if an app gets into that DIGA system, every statutory health insurance in Germany has to reimburse it for their patients, which means 90% of the German population would be covered by that. It's mandated that the patients have an existing indication or condition diagnosis. So it's usually prescribed by a doctor. They would give a diagnosis, then they would prescribe the DIGA. Also, if you have a diagnosis already, you could also direct a request from health insurance, and then it's paid for. It covers usually a 90-day prescription. So you usually get it for 90 days. You can also get follow-on prescriptions. The process to get in there is a kind of fast-track system that usually goes over three months. You have to apply. You have to either get in preliminary if you have certain early indications that might work, or you can already apply for permanent listing. If you apply for the preliminary one, you then have 12 months to prove that you should be permanently listed. There's a Federal Institute deciding over this, and usually, 98% of those DIGAs that are currently listed have done a randomized controlled trial to show that they really work. That's kind of the system. Pricing for the first year, you can set the price yourself. Afterwards, it's done by negotiation between the manufacturer and the health insurances, and then, yeah, there you go. That's the ecosystem.

Samantha Jérusalmy 02:45
It sounds like there's a lot of positives to this, but I wonder if we could talk about some of the constraints that it might impose on a company, or maybe some of the more difficult things about it. Laurent, you just came into my view. Do you want to touch on that a little bit?

Laurent Pacheco 02:59
So indeed, there are opportunities getting reimbursements, but it's under conditions which respect the framework. So you need to develop your dossier. There are guidelines for that, obviously. But that in itself is a bit constraining, and you need to demonstrate value. This is the very purpose of reimbursement. If we expand a bit beyond DIGA, there is a lot of movement in Europe, and each country, unfortunately, can think deals by themselves on reimbursement matters. So the DIGA framework is not the same as the French framework or UK framework. There exists as well. We discuss DIGA today because it was one of the first ones in Europe, and it has inspired others. But my point is that fragmentation in Europe creates difficulties for companies. You can hardly have one product, one development for it, which is what we want to do, and then have specific requirements. So the higher standard you could go would be RCTs. It is needed for France. It's an obligation to be randomized to be reimbursed. It is helpful in Germany, so you see the variability. So the constraint is very much understanding how this fragmented world creates obligations, knowing that you will hardly be able to develop your product, the actual development R&D specifically for each. So how do you define, how do you design your development strategy that would match as many markets as possible?

Amine Benmoussa 04:38
Okay, and you know, there's a difference sometimes in talking about just how to get into a framework versus how to do it successfully long term. Do you want to speak to that a little bit?

Samantha Jérusalmy 04:48
Sure. Maybe to go back to what has been said. So we're a France-based fund, but we invest in early-stage companies across Europe, and we have all the time this question about the go-to-market application, either if you started from France, or you go to Germany, or you go to the UK, or somewhere else in Europe, and so on. And what will be the best track? As it has been said, on each country, this fragmentation that started, or this great initiative that started in Germany, to stay positive, because it was a great initiative that started in Germany in 2020, I guess. And it gave the path towards others. So we have the PECAN, for example, in France that happened a couple of years after that, benefiting from this fast track for application as well. And we have a couple of companies that started this track. This is long. You need clinical evidence. But come on, we're talking about patients. So it's normal that we need clinical evidence. But as it has been said, it has been fragmented on each country. So you have the DIGA in Germany, you have PEC in France, you have the MDR for all medical devices across Europe. You have another track in the UK, you have another track in Norway. So this fragmentation, it's a difficulty, but at the same time, it can be an opportunity for the ones that succeed in having this. So to go back to your question, this is something that we have to understand when we invest in a company, and this is the question that we ask ourselves: what will be the best go-to-market strategy? I don't know how many entrepreneurs are in the room. I guess some of you started to have this conversation, either with your investor or with your colleagues and so on. But you have to find the right go-to-market strategy, and you have to start quite early in terms of regulatory proof, speaking to all the partnerships that you can gather. You have to, for example, in France, you have to talk to the HAS. In Germany, maybe you have to talk to other players and so on, to make sure that you follow the right path for your own. So we have some companies that started in France that want to go for the DIGA and are now going to the US. So this is the kind of discussion that you have to have with your investor, with your colleagues, to make sure that you find out the right track.

Martin Mueller 07:17
That makes sense. And I appreciate you going into the detail around that. When I think of a particular framework like this, there are sometimes unwritten rules. You can go online. Maybe you can read the documents about them. Hopefully, you can read German, I don't know. But if there is an English version, I've heard different things about that. Maybe we could talk about things only, though. But what about the unwritten rules? Are there any unspoken rules that are just understood in the industry? Is there anything that comes to mind? Amine, I'm looking at you and putting you on the spot here. This is a more difficult one, but any thoughts?

Amine Benmoussa 07:50
Yeah, happy to take a crack at it. I mean, maybe not unwritten rules, but a lot of learnings over the years. I mean, yes, it's been a great initiative, and yes, it helped a lot of companies push innovation forward because there is this framework that allows for reimbursement. A lot of companies—there are about 60 to 70 DIGAs right now—companies that have a DIGA approved product in Germany, and many of them, because of what Martin mentioned about the whole pathway where you get reimbursed for a temporary period over the first year, and then you have to go back and demonstrate your clinical evidence and get reimbursement. One of the unwritten rules, or something that a lot of companies overlooked, was that the government can go back and claw back any money you got. So you had a lot of companies, when they got final pricing, they got reimbursed for like 12 months for, let's say, 240 euros per patient per quarter. But then the final price ended up being 180 per patient per quarter. So the government can go and claw back that money, putting a lot of companies in a very, very tough cash position. That's number one. Number two, I think a lot of companies and investors alike were so charmed by this DIGA model that people thought these therapeutics were going to prescribe themselves just because there is reimbursement. And while these digital therapeutics hold great promise, they're no different than pills. You have to have, as Samantha mentioned, you have to have a strategy to go out and market those products and make sure you have prescribers prescribing them. And then the third, maybe thing that ties up to the two previous ones is a lot of companies, I would say, had some sort of false positive, where we saw some very good traction at the beginning. So a product is put on the market, they get DIGA reimbursement, and then you see sales take off in a very, very positive way, but then very quickly start plateauing. And that's because physicians, just like the vast majority of the population, have different kinds of people, including some very early adopters. So you have prescribers who are just happy to test something new. A lot of these companies saw that early spike, but very quickly it started plateauing because these companies didn't live up to the expectations in terms of demonstrating further the clinical validity of these products and really pushing them commercially. Which brings me to maybe one of the fourth things about DIGA, one of the unwritten rules. When you are in DIGA, you are not allowed to use clinical data and publish on it. If you publish on the data you have, you get excluded; you get banned from the DIGA system. That's, in my opinion, one of the major flaws of DIGA. So how can you as a company be expected to generate and publish additional clinical data that's going to help you get to the second phase of prescribers, beyond the early adopters, if you're not allowed to do so?

Samantha Jérusalmy 11:06
Go ahead, Martin.

Martin Mueller 11:07
Yeah, maybe to go back to what Amine just said. I think the points raised by Amine and Samantha are great. Maybe to the first one, Amine raised data pricing. That's a really big thing. Yeah, it can kill a company. It has killed companies. Yeah? So just to play maybe in detail, like the first year, you can set your own price. After the first year, you have to go into negotiations. And these negotiations tend to linger a bit longer. Yeah, then, if you then, let's say, in the 18th month, get the final price, then whatever has been prescribed in those six months after the first year, the difference between the final price and the price you set yourself, you have to pay back. So to me, to be honest, if that kills a company, that's misplanning. Like, it's not an unwritten rule; let's say it is written. Yeah. And so to me, if I talk to these companies, I'll be honest, they should put anything above 200 euros that they then get into a bank account somewhere and just not spend it. Yeah? Because obviously, we now know that the final price is usually never above 200 euros. And then there you go, the whole thing about the prescription and how that has killed the hype, maybe on our side, especially, I think that's a huge thing. Yeah, like, I guess initially we all thought, "Ah, now it's all prescribed. Everyone takes it, everyone gets it, awesome, huge market, great." But now we have these gatekeepers, these doctors, right? And we really, I think, learned that there's a lot of education necessary, as Samantha alluded to here, right? It's even getting a new pill on the market. Pharma companies usually have huge sales rep teams, and they tell them about it, and they spend a lot of money on it. These digital health companies usually are much smaller. They don't have these kinds of sales reps. And then even the flip side, I think the effort is even higher because you have much education here. Every doctor knows from their studies that generally pills work. Yes, this specific pill works a bit differently, but generally, all medical doctors believe that pills work. With the apps, it's a whole new thing. Yeah, you have to explain to them why an app might work. You have to build a lot of education in the market, and that just takes time, money, resources, and, yeah, not just in Germany, in every country, and it will be a while, I guess.

Laurent Pacheco 15:06
I think you had some comments on pricing.

Laurent Pacheco 15:06
Yes, another comment. The pricing model for these solutions is multiple. There is the price that your business will get, right, but there is the price that your healthcare professional or the revenue will get as well. So even if you fight for yours, you must take into account, of course, the broader economic picture because it may be capped, from a physician perspective, in terms of how many patients they would be paid for looking after with these types of solutions. And it's also a time matter because they could handle patients in a way rather than another, and they may even, if it doesn't sound so right, have a sort of economic incentive as well in terms of their own prescribing physicians' behavior. It is important for you—not for your DIGA application, right?—but for you to understand the context and the implications of that broader economics in terms of the potential uptake. So basically, your forecast, I wanted to come back also in terms of unspoken rules on the way you can or maybe should approach the young and others, right? This type of mapping is very important, and also it helps you understand what could be or would be expected, even if it's not so, namely, written in a specific guideline for Germany, for example. Typically, you would know you need to demonstrate benefit effectiveness; you need to be compliant with GDPR. There would have to be some sort of interoperability, right? That is what many Germans would say, right? But if you explore what is said, what is expected elsewhere in France, for example, beyond the agency that dictates or decides on the access for investment, there is a close link with the National Agency for Digital Health, which is a different matter. And you are linked to that, and you explore that, and you will find, actually, a number of other boxes to tick. They will start with usability. You have accessibility. There is durability, right? There is interoperability as well. And of course, you have the typical effectiveness data compliance. So you see there are actually many more concepts, even if maybe it can fit in other broader ones. But that mapping really helps you understand how each of them would see what's needed. If you onboard that early in your development, of course, the earlier the better, right? It's the best way for you to tick as many boxes as possible. And in some places, even if not explicitly expected, right? In the guidelines, this won't be one of these unspoken rules that they would want and they would like to see.

Samantha Jérusalmy 18:00
Yeah, maybe to go back to what has been said, not unspoken rules, but build strong partnerships with key stakeholders. We're talking about the fact that startups don't have the money to spread, like many people on the ground, like feeding with some education for patients, for prescribers, and so on. But if you build key partnerships—and we've been succeeding in a couple of companies from our portfolio—with pharma companies, for example, because they have tons of people that can go on the ground, because they go on the ground for pills and so on. But they need this real-world data, right? They need this real-world evidence to make sure that their pills are working as well, and we tend to build that kind of key partnership. At the same time, we try to go toward the strike beyond the reimbursement part to make sure that we have those people on the ground that can help. It can be other stakeholders. It can be insurers. But when you want to go to either France, Germany, or so on, make sure that you build strong partnerships. It might take long, but if you have both tracks with the key partnerships and the reimbursement part, at the end, you have those two tracks that can help you to make money, right, and to gather much more data that we are mentioning as well. So I guess maybe key partnerships with key stakeholders, insurance, pharma companies, and people on the ground can help.

Martin Mueller 19:35
That's a good point. Yeah, so in general, we as doctors like listening to other doctors who have fancy titles. So if you have those on your side, yeah, those key opinion leaders, they are at conferences, speak about your DIGA, or you have some key prescribers who prescribe a lot, talk positively about the experience. I think that can help a lot. Yeah, the pharma part, I'm hearing mixed things about. Yeah. So what I hear sometimes is awesome partnerships, and then these sales reps go out and they have three medications, drugs, and then maybe some device, and then their DIGA they want to talk about. They only get, obviously, very limited time when they are with the doctor. And then often the DIGA is a bit forgotten about because also, for these pharma sales reps, right? It's not their natural thing. They're often chemists or whatever, right? So, and then also, I wonder a bit about incentives for pharma. So obviously, what DIGA can often do is increase adherence; they usually have like a medication reminder part or often have, on the other hand, if we think digital therapeutics to the end, they often have like a kind of prevention or secondary prevention part of it, yeah, where they help you in a mental health kind of way or help you feel better without taking drugs. So if they work, they might reduce the number of drugs being needed, right? Because people feel better another way. So sometimes I wonder, how does pharma really feel about that?

Amine Benmoussa 20:48
To give an example, we have a company named TLAC that is doing remote patient monitoring for patients that have ophthalmologic diseases. They had a strong partnership with the pharma industry because basically what they were doing is sending alerts to the ophthalmologist, saying, "Okay, so this patient, you have an injection projected in six months from now, but his vision is really decreasing right now, so you have to make the injection right now." So it's not really competitive with, for example, Novartis or Bayer that is selling this injection to the ophthalmology. So here it's really complementary, I would say. But you're right, from time to time, for example, in the neurology space, right, we try to say that invasive treatment might be not as good as non-invasive treatment with applications and so on. In here, it might be competitive.

Amine Benmoussa 21:49
Yeah, I mean, I just want to double-click on, I agree with both of you, but I think one thing that we should remember, there is a massive opportunity for sure in the B2B partnerships with pharma and what have you. But I don't think the current generation of digital therapeutics is going to have much success in that. The reason I'm saying that is because most, if not almost all, digital therapeutics of this first generation are not of interest to Big Pharma. They're typically very low risk, class A, class one, whatever you want to call it, but like bare bone, in terms of complexity. We're talking about digital therapeutics for addiction to nicotine or erectile dysfunction. If you put it on a spectrum, we're far, far from oncology, for example. So I think as we get to more second and third generation digital therapeutics, there are a lot more complex that are targeting much more complex diseases where Big Pharma has very high margins but also very high costs in terms of manufacturing. Then there is probably a huge opportunity for digital therapeutics to come in and be sort of an amplifier for their own bottom line, as opposed to sort of competing or cannibalizing some of their sales.

Laurent Pacheco 23:12
I mean, you go ahead.

Laurent Pacheco 23:12
Just in terms of partners. Yes, beyond pharma, what matters for these decision-making agencies is how you are also connected to decision makers, as in KOLs, but also care centers. And depending on the country, you may have funding. So actually, there are different types of funding or reimbursement. It can be before launch. There can be coverage as you are developing, which is a sort of coverage with evidence development, as they have in the US. There could be a temporary one year, which is a sort of low soft launch; we check during one year, and based on that evidence, we decide on whether to stabilize that over time. And there is another one which is funding for pilots, and pilots mean having your healthcare setting, your Mayo Clinic locally, ideally, with which you partner to test the solution. And actually, you get funded for that, even if it's again part of development. But the great thing is, you have a great partner if you manage to, and when you get to develop your dossier, this is named, of course, and it has unspoken value, right, but obvious value, though. So choose not only industrial for development but also such visible organizations to support. And back to this point, also you said earlier, Samantha, with your example, there is a patient benefit, but it's also a care pathway or care system benefit. The DIGA, the German way, is very patient-centered, perfect as it should be. In France, there is a bit of a nuance where they say we can also fund for solutions that help support improving operations, as in operational efficiency. And that very much fits with your healthcare system partner because that would be very much a demonstration of how the thing works in a process way, not just in a patient outcome way. So if you dig that, you find you have a benefit in potentially being funded for your pilot; you onboard a great partner for visibility.

Amine Benmoussa 25:23
You had mentioned earlier about how you shouldn't let this pathway necessarily dictate your approach because you should be following the appropriate way anyway. Sometimes I feel like our tools shape our tools, and then our tools shape us, and maybe that's the way this is to a certain degree. Our framework could be shaping the way we develop medical devices and digital health applications? How do you reconcile that? And do you have any suggestions on this local approach and then integrating that into a more global approach? You touched on that to a certain degree, but can you expand?

Samantha Jérusalmy 25:55
This is a harsh—I mean, I think that there is no generalistic answer to this question because depending on the market that you're targeting, on the therapeutic area that you're targeting, we've done a couple of investments in remote patient monitoring or digital therapeutics. But even this term digital therapeutics, I'm not a big fan of this because it's not therapeutics. I mean, there are things that are really valid, like reshaping the way we treat patients, your mental health kind of aspect, exactly. But in other cases, in most cases, it's much more a way to get again real-world data to make the patient pathway better, optimize, and so on. So, for example, we've done TLAC in a very specific therapeutic area in the ophthalmology space. It happens that we started in France, and the company was asking and selling the question about the go-to-market: either we go to another European region or we go to the US. We decided to go to the US. Why? Because the market is there. So this is the first main reason. They're much more inclined and matter in that kind of application. They're much more competitive as well, but the doctors and the patients are much more mature in terms of usage. So this education that we're talking about, it's well done, and it has been done in the last past years in the US. And we figured out that in terms of DIGA, what is succeeding in France, the fact that the prescriber is well incentivized for prescribing, this might not be exactly the case in Germany in terms of the amount that the prescriber is taking each time they prescribe. In France, it's kind of generous. So it makes a difference when you're prescribing versus not prescribing, and since you're changing a little bit the way they're prescribing, it makes sense for them in an economically speaking way, right? So for this company, we decided to go to the US. For another company that we just invested in, Douglas, is an agnostic, holistic remote patient monitoring company that has been in the UK. They started in the UK, very centralized NHS; they have tons of good references in the UK. And the question is, where do we go now? They decided to go in Europe. So France, Germany. So they're going to stick in Europe as of today. But the main stake is to go in Germany and France. Why? Because it's very much competitive in the US. Too much competitive in the US. And there are some tribes that might be interesting. But if you paralyze what they have been doing in the UK with the NHS, in Germany, in France, it doesn't work. It doesn't work exactly like the same. In the UK, it's really centralized; in Germany, it's really regional; in France, you have to know AJ, E, PHP, and you have to get some quick wins like this with private clinics and public sectors as well. So I have to say that I don't have a generic answer. I'm sorry, and it really depends on who you are and where your market is and what's the competition and maybe the exit strategy, but that's another matter.

Martin Mueller 29:29
Go ahead.

Martin Mueller 29:31
So first, you mentioned the economic incentives for physicians to prescribe them. There is one in Germany as well. Right? In Germany, private physicians have a budget of what they can administer, therapies they can administer per patient. DIGAs currently do not count towards the budget, so they can pretty much prescribe for free right now. So I think that is quite a strong incentive, incentivizing even further. I don't know, at some point it's also their job. Yeah, they should know about the therapeutic options they have for their patients. DIGA is one of them. So I should know about it. And now we increase it a bit further because we just changed the system where now monitoring apps are kind of also possible, and there can be more involvement from the doctor. And for that time, they actually do get certain reimbursements, doctors. So there is maybe now something, but the prescription itself, I don't know. I think it's their job in terms of going to market and being more international. Yeah, also, usually we advise our companies to go to the US first because it's one country, right? It's one country, 300 million people. Of course, they have differences from state to state and the different health insurance, but it's definitely more unified in Europe. And unfortunately, with the way politics are going in Europe now, and everyone voting for very nationalist governments, I can hardly see it becoming more unified, even maybe less. Ideally, you would have one unified system across Europe, but I can hardly imagine seeing it coming.

Laurent Pacheco 30:52
If there are some representatives of regulatory authorities or whatever harmonization, please. It will be easier for a startup.

Amine Benmoussa 31:01
We are working on it, but go ahead, Laurent.

Laurent Pacheco 31:03
Harmonization, we manage pretty well on the regulatory side because science has no borders, no color, no language. Economics is a different animal, right? Because it's anchored in budgets. And actually, you don't have a European healthcare budget. It's still, as you know, at best, country by country, but more often it's region by region, in Germany or Italy or Spain. So you cannot have one coverage decision that fits for all because historically as well, what happens is the marketplace is different. You don't have the same products in France as in Germany, as in Spain, 100%. As a market, that means that your comparator is different. When they decide the price, it's actually based on what is already available, the same as they do for France, right? What matters is the incremental benefit, but that depends on what is your comparator, the anchor point. So since those markets are different, we cannot get to the same definition of what is the value add and what would be the price for all. So unfortunately, fragmentation is here to last. The other aspect is culturally, how are these countries or agencies handling the assessment? There is, again, the distinction between regulatory and reimbursement assessment, which is via the HTA health technology assessment route in drugs for molecules, is quite well separated, different matters. Interestingly, for digital, the agency in Germany that assesses whether or not it's going to get reimbursement is the regulatory body, BfArM, not the usual health technology assessment such as GBA, right, that we would have for drugs. In France, it is as for drugs, the same body, not the regulatory one that's typically after regulation would discuss the matter of reimbursement, and they have within that two groups: one is more sense of tech-based, the other is economics-based. And for your digital health influence, you need to have a very specific health economics case because this is the mindset of HTA. Again, not so much regulatory. And that goes beyond the cost to the budget of France if it gets reimbursed. It even goes beyond the patient benefits that are quantified, as in health economics benefit. We can do that. It gets quite tricky, but it's more and more expected. You may have heard of cost per QALYs, and eventually, as discussed earlier, they benefit in terms of getting the system to work better, the overall French healthcare system gets more productive. There would be expectations; you may or may not be able to quantify that. But if you play, as we said, with the pilot, with the partner, and work on accelerating, improving, which is around the productivity of the system, quantify that, and this would be very well assessed by French or English assessors, whereas, again, in Germany, it's quite a different approach, not that economic.

Amine Benmoussa 34:12
I want to ask you very quickly about the evidence that you mentioned. You said you can't publish on the evidence that you have once you're in the directory. How can you use—so when I first started hearing about this, I thought, "Well, that seems like a great way to market so that you could leverage that data for other markets." Do you have any comments on that or how to integrate that into a more global strategy?

Amine Benmoussa 34:35
Just before you asked me the question, I was going to go in a different direction, but I'll gladly answer your question. I was going to say that I derive a lot of pleasure from criticizing Europe and the regulatory environment and reimbursement, but Samantha and Martin have done an amazing job, so I'll try to take it in a different direction. But now you're pushing me again to be critical. I think even if you were able to leverage that data, for some reason, European regulatory authorities believe that a German human being is not, for some reason, the same as a French human being. And the French authorities—like we're living through that with PECAN, which is the DIGA equivalent in French—but for the French, they believe it's better because it's French, you know? So the French authorities do have to negotiate to be able to reuse some of the evidence you've generated in Germany, or they will ask you to conduct new clinical trials. So if you've demonstrated, I'll take a case of a portfolio company, if you've demonstrated in an RCT that your digital therapeutic actually works better than Viagra for erectile dysfunction, both in naive patients and patients who are on the drug in Germany, why would that not work in France? Why would you have to go and conduct a new clinical trial in France?

Laurent Pacheco 35:59
It's a very specific case. Yeah, maybe I understand why the French consider themselves different.

Amine Benmoussa 36:03
Yeah, well, they believe there's no market for that in France. But that's again, yet another issue. But if I can go back and just double-click on the whole issue about the regulatory and reimbursement nightmare in Europe? Yes, fully agreed. But if I can be fair for a moment, it's not that simple in the US either. Yes, it's a unified country. But then you have Medicare, you have Medicaid, you have people who are on private payer programs. You have hospitals that are fee-for-service and others that are value-based, and like within the same hospital system, you're dealing with a very complex payer mix. So it's not that easy. I would say that, in my opinion, if you're only relying on reimbursement as a company, you're not going to be building a world-class company. It's great; it gives you a good kick start. But if you ace your value proposition, going back to what you were mentioning about not disrupting workflow, about value for patients, value for providers, if you really nail that, you build a world-class company, and your solution gets adopted, no matter whether you get reimbursement or not, because people will perceive a huge value for the technology. I think it really relies there. A lot of companies today are just relying on DIGA reimbursement alone. I mean, we've seen that. We've seen some companies in the past 6 to 12 months in Europe who got DIGA and who are getting very close to the fringe of bankruptcy because they have not been able to sustain the promise.

Samantha Jérusalmy 37:44
So we are at one minute. So let's go into a quick lightning round. If you're speaking to a digital health application company out there, what's your one piece of advice that you want to give them? You have 10 seconds. Go ahead.

Amine Benmoussa 37:58
Come by, say hello to Elaia, because we're still raising money; we still have some room for companies in this space. So I'd be welcome to talk.

Martin Mueller 38:09
Really nail your strategy on how to talk to doctors that you're the app to prescribe for this condition you're targeting.

Samantha Jérusalmy 38:17
I'll have a few, but quick: understand the marketplace and the requirements very early, right? So you develop with that in mind, as opposed to making the most of your development last minute. We haven't touched so much on competition; I just insist that it wants to be a comparative exercise. Most of what we see today is quite novel. So value in absolute terms is good, but quite soon it's going to be quite crowded, right? So, yes, you do that and this and that, great, but how different?

Amine Benmoussa 38:49
I would say, forget about the first generation DTX. Simple stuff. Be some of the first to serve the wave of much more complex DTX because I think there is a huge opportunity there.

Samantha Jérusalmy 39:01
Incredibly passionate about what they do, so definitely talk to them afterwards. But thank you so much for your attention, and enjoy the rest of the conference.