Medsider: Learn from Medtech and Healthtech Founders and CEOs - Maximize Market Opportunity, Minimize Feedback Loops: Interview with SAVA Co-founders Rafaël Michali and Renato Circi

Episode Date: January 8, 2025

In this episode of Medsider Radio, we had a great chat with Rafaël Michali and Renato Circi, co-founders of SAVA, a London-based biotechnology startup developing a novel biosensing platform to monitor molecules just below the skin in real time.Rafaël and Renato are biomedical engineers from Imperial College London. Both recognized in the Forbes 30 Under 30 list as some of Europe’s most promising young innovators in 2018, the duo raised $13M in funding and built a cross-functional team of now over 40 to develop a next-generation biosensing platform. Together, they built a thesis surrounding preventative health, from which SAVA was formed: redefining healthcare into a system that is accessible, personalized, and preventative.In this interview, they talk about the value of identifying a large market with substantial opportunity, how they moved rapidly through development iterations, the right time to exit stealth mode, and the complexities of building a medical device.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Rafaël Michali and Renato Circi. 

What is the critical thing that you have to demonstrate to have people be in your idea? But often when you start being the picture about, okay, what is truly unique about the part that you do, you can distill it to me a core few things, and that's the only things that you have to focus on. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics and secrets behind the most successful. life science startups in the world. Now here's your host, Scott Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Raphael and Renato, co-founders of Sava, who are both biomedical engineers from Imperial College London. Both

recognized in the Forbes 30 under 30 list as some of Europe's most promising young innovators in 2018. The duo has raised over $13 million in funding and built a cross-functional team of now over 40 people to develop a next-generation biosensing platform. Here for you, the key things that we discussed in this comment. First, bringing a medical device to clinical trials, let alone commercializing them is a massive challenge. If you need a large enough market to justify the investment, once you have an idea, leverage resources to iterate quickly and cost-effectively and prove core functionality to win over investors and partners. Second, during the early development phases, staying under the radar helps shield you from external pressures and allows you to focus on proving your core functionalities. On the other hand, going public increases awareness of your company.

A good time to exit stealth mode is when you reach a predictable development path. development path where major scientific risks are addressed and the technology is proven. Third, don't choose the easy route to market. Aim to address multiple use cases and market segments like Saba is doing with its microsensor platform technology. Seize the opportunity, even if it means navigating stricter regulatory requirements and securing more funding, as long as you're solving a clear gap that is disruptive in nature. All right, before we dive into this episode, I'm pumped to share that volume 7 of MedSider Mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter,

CEO of Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safion, and current CEO of Corvista Health, and other proven MedTech founders and CEOs. Look, we get it. Keeping up with every Med-Sider interview isn't easy. That's why we created Medsider mentors. These e-book volumes distilled the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanking new features, especially for our premium

members. In addition to every volume of Medsider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider playbooks, curated guides, path with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more. And if you're fundraising, don't miss our exclusive investor database featuring over 750 life science vCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive in the interview. All right.

Rafa, Ren, Sava. Pleasure to have you guys on the Med Sider program. This is a bit unique, right? Because I usually just do one-on-one interviews, but cool, cool opportunity to have both of you guys on since you're both founders of Sava. But I recorded a very brief bio on your backgrounds at the outset of this interview. But I always like to start there first, right? If you can maybe provide a very short elevator pitch on what you guys were doing prior to Sava,

let's start there before we rewind the clock a bit. Awesome. Thank you for having us. So I guess, Radford and I have a pretty similar background in the sense that we go way back. We maybe met around 10 years ago in the labs at Imperial College in London studying in the world of biomedical engineering, but specifically in the world of biosensor technologies. So we're both practical. Engineers by background training focused a lot in everything and any sort of technologies that can really change the worry that we monitor across.

That's pretty much what we do create in, and that's what we got immersed by, So we got passionate about it just really early on in a lot of careers. We met as friends initially, then as Weishaf Bodies, and then eventually as co-founder, as we started working together on a fact that the story is still ongoing, where we're still trying to, basically develop the whole new technology based on, yeah, that makes me that allow us to just reinvent the way that people to monitor our own cost. Very short way of saying it, that's a very narrow background is, and we've got into the digital stories that probably could check for a way longer,

but that's pretty much a little bit of us since that's really a little bit of us in this is a really. There's enough there, right? To set the stage for the rest of the conversation. But so Sava, I'm looking at the website now, which is Sava Health for everyone listening. If you don't get a chance to get to the full write-up, it's S-A-V-A-Halth is the website. But it gives us a high-level overview of kind of what you're building as well as where the company's at in terms of kind of stage. Yeah, we're in a nutshell, it's how we developed the whole new piece of technology, which is just re-implanting the radar we can monitor our own health. The whole idea is basically we both share the vision that the future of health is going to be preventative.

This is going to be enabled by transitioning with specialists, lab-based technologies that enable us to monitor our health with the deepest levels, away from centralized labs to directly the consumer, the rest of the patient. And although the wearable movement is something that we got really excited about in recent years,

there's still a lot that we can improve in terms of how we can and the level of information that we can get. Because most of these wearables like Apple Watches, tidbits, garments, ororing, are basically only built for peripheral matches, stuff like heart rate and stuff like sleigh in basically activity, but everything else, and when you look at the next dimensionally,

the very molecules that flow into your body, that's when things become very difficult. So we're basically building a next generation and wearable platform that allows us to do continuous monitoring of the molecules that flow just below your skin. We can do that in real time with a system that is completely painless, it's flawless.

You just simply put it on your arm, reconnect it to your phone. It streamlines and analyzes everything in real time and sends all the information directly to your phone. Starting with blood sugar, so glucose levels, initially, but eventually really building the bathrooms that can do a vast variety of different molecules in real time, just completely changing the whole paradigm of sensing that is going away from sanctuary lab that is medical device centered, which is lab dependence to something that is

completely effortless the patient, direct to the consumer. Got it, got it. And you mentioned wearables and starting with CGMs. I think there's probably a healthy percentage of those listening that are familiar with Abbott's sleeper device for CGM. Can you briefly touch on maybe how your device is different? and I wouldn't expect you to unveil confidential information, if you will, but maybe just frame it up for like how is your approach different, is the device itself different, maybe just add a little context there? Actually, if we take a step back and we look at like when we started the company,

which is about five years ago now, but even before this, when we were building our pieces around health, we were like, are there any devices that can monitor our health outside of a lab? And the only devices out there that exist and were actually, continues with those monitors. So when we actually grabbed the CGM for short, we're like, these are amazing. They can monitor a molecule below your skin without having to go to a lot. So for us, this was like a glimpse into the future, but we still realized that they had three major pinpoints. The first one being user experience, so CGMs are incredible, revolutionized

the way patients with diabetes access their health instead of fingerprinting, they can actually monitor their rucose levels in real-time dose-year incident. But for, I suppose, the everything individual, but even beyond type 1 diabetes for patients who, which are like type 2 diabetes, the user experience is still, in our view, not good enough. You have to insert a filament using hyacrolamic needle. And most of the time, it's painless,

but when it actually, when the insertion process is not good, it actually hurts a lot. you get maybe some listeners have filmed this but you essentially have blood coming out of the device it's not great so we're like okay this has to change and you have to find a better way of doing it the second one was cost few gems are great but they're actually very costly

for a two-week usage is about like $50 if you chocolate this in two year it's actually much more expensive than a traditional like Apple watch should say and the third one was like the ability to monitor more than one molecule at times. So these games have been built to monitor one molecule at time. Maybe the freestyle we might be able to do two molecules at some point,

but beyond this would be pretty much impossible. So the only way for us to solve this is to actually build our own product, and that's how Sava came about. And so the way we've created this product, and he's built everything from scratch, based on a technology that we engineered based on microsensors so they're very tiny sensors that penetrate just the fourth area of skin which still access the same fluid that CGMs access

so into social fluid as clinically robust as a CGM but they sit above nerve endings and capillary so they're essentially completely painless the second pain point is cost so the aim is to be able to produce each device at one tenth of a cost and give anyone the ability to use a CGM regardless of where they live. So this would include developing countries. And the third one, our ability and how we engineer the system is to be able to function like each microsensors to be specific to a different molecule. So you would be able to monitor more than one molecule at a time and provide someone with

a holistic view of the end up. Got it, got it. Cool. If you guys could pull this off, I think you're on to something. I mentioned this before we hit the record button, but one of the companies I founded before Fastwave was Juve. And so I got to know a lot of the folks in this sort of anti-aging longevity space. Before, I think it was popular, I would say.

So like this was, I got to know the folks, the original founders of aura that you mentioned. This was before Woop was even on the scene. The Apple Watch was not great. And then I had a chance to participate in Levels beta program. I think that they may have incorporated the Dexcom device now, but at the time it was Abbot's Libra device. And yeah, even the Libre device is not, it's not great to insert.

Oftentimes it doesn't fail, right? Upon insertion, it's kind of pain to wear. It's a little bit big, a little bit bulky. You're going to replace it every couple weeks. And yeah, you guys, it sounds like your technology delivers a lot more potential value than what's available currently. So with that said, give us, I know you recently raised a pretty sizable seed round and came out of cells.

At this point in time, we're recording this mid-20204. Or are you guys, like, kind of, again, at a macro level, where are you at terms of stage at the stage of the company? Highly focused on design and development. Are you looking to get into the trials at some point? Give us a sense for that. Yeah, it took quite some times to actually get to the 12 yard yesterday. So the five years where we were under the radar, which is being busy in development.

And I guess we, the bottom line is we reached a level where we're very confident with the products. So building a medical device is a very challenging. problem, especially if it's a heavily regulated industry, and right now, when you look at the CJA space, most of the benchmarks that we have are very well-performing products, right, which are very high accuracy standards. And this is a back and effective word right now that expectation of performance really is. And that's what we're benchmarking against as well. So over the year is getting a system that initially was just a proof of concept that worked for a couple of hours to getting a system now that can work for multiple days, is something that requires a lot of iterations, a lot of optimization.

We're at a stage now where even to get clinical studies, at least this is particularly true in Europe, in the UK. There's a robust regulatory process that you have to go through to even get a green light to kick off a clinical study. And we're at the point now where we just got clearance to get started with our clinical studies in diabetes, with our basically our new microsensitive platform, which we have confidence will demonstrate comparative performance in terms of see Jennifer Market today. Yeah. He didn't have approval to get started. This year, by the end of the year, we expect to have medical data coming in.

So it's a very exciting slot because it's really getting to a point where we'd be able to show that our system actually has the capability of performing, like other C gems, the market can, which is something that, at least in this format, it's something that is meaning and basic, someone's yet to prove in a meaningful fashion. So that's pretty much familiar we are, which is why we thought this is the right to know to come out of stealth because actually the value that we have, the weekend in Vail that actually gets us really excited and hopefully you can get out of people. I'm really excited as well.

Oh, yeah, no doubt. I had Brian Fahy on the program recently. He's the CEO, co-founder, co-founder's CEO of Adana, Adana Medical, in the Hartfelter space. If we were talking about this, the two kind of like super exciting inflection points for any kind of startup in the, and the MetTac, West Side of space is like getting into patients for the first time and then launching, eventually launching in some sort of fashion.

Those are two pretty exciting times. So with that said, let's take the chance to rewind the clock and step inside the old MedSider time machine, as I like to call it, and run through a couple, couple, a handful of different kind of functional questions around key functions that any startup has to run through in order to get to a certain stage. So first one on the docket is it's really around choosing an idea, right? So there's a lot of folks that listen to this podcast that are in the space, have some ideas around something, but haven't pulled a trigger, right? Have it taken a swing. And you guys made that decision clearly and are onto something. So when you think about other folks in your network, any advice for those that are somewhat on the sidelines, trying to choose an idea, trying to determine. and whether or not to move forward with a certain concept, any high-level recommendations for those would-be entrepreneurs? I suppose in the MetTech space is different than, let's say, the SaaS industry.

In the SaaS industry, you can have two quarters in a basement, build an MDT, launch, make a couple thousand dollars a month, and from there, actually, Renan and I started from an underground loud, and it was just the two of us in the lab. So this still has to happen, but in the clinical device space, in order to reach a product that can go to clinical trials, that can go into the market,

where you actually can spend money as probably better than us, you need a lot of capital. So I think the way to think about it if you're building a medical device company should be very different than the way you think about it when you deal with a SaaS company. obviously. And so

for a medical device company, I don't know what you think about it, but the way I'm thinking about it right now is that the overall impact that you can have should be probably I don't know, 100x

or 1000x, any impact that any SaaS company on paper will have because the amount of work and the amount of money that would be required just to reach that first in human trial just to reach that first

just to reach that first launch is so high that the journey and the mission has to be like four greater so it's not a direct this is when you should pull the sugar but I think that

when you're actually looking through your ideas when we started we're comparing idea buckets we have whatever 20 30 ideas each some of them in the lead tech some of them in the consumer space we ended up choosing something cross over between MetTech,

consumers, but definitely for the more challenging ideas and we're like, okay, this has to be this has to be to revolutionize the way everyone interacts with their health. Otherwise, it's not really worth it. Yeah, and that's good feedback. It reminds me of the, and I can't

remember if Mark Andrewsson popularized this or Ben-in-Morowitz, I don't recall exactly, but like this question of like product marketing, what's most important? And all three, legs of that stool are important. But in MetTech, especially, market is crucial, right? Because if the market's not big enough to support a venture-style investment, most likely the idea is just not going to, it's not going to ever amount to anything, because almost all of these projects require not only a lot of capital, but also a lot of time, right? Even with that potentially a reasonably fast

return or exit, you're still staring down seven, probably seven, eight years, roughly, which is like almost a fifth of someone's working career. And so it's a lot of capital, a lot of time. And so I think you hit on a couple really key things to think about, right, if you're staring down an idea or trying to make it a determination of whether or not something is worth this way. But kind of a similar vein, you guys are both, you guys have extensive engineering backgrounds. I think this is especially interesting to think about because of your device has a very consumer kind of bent. But when you think about one of the hardest challenges for any startup, but especially those in MetTac,

is trying to like iterate on early stage concepts with pretty limited capital, right? It's so hard. You're just, you're trying to pass things together, make iterations just so you can demonstrate some sort of a simulence of trajectory. And so when it comes to advice around that topic specific, how do you do more with less in those very earliest stages?

Any key tips or key things that you guys have learned, whether it's at Sava or elsewhere? Foremost as a as a risk or slow or as crappy as you possibly can be. Aspera help, find ways in which you can leverage resources. And if you look, you actually end up finding more research than you think you have available. But I think the other one ultimately goes down to what is the critical thing that you have to demonstrate to have people be in your idea. And often it's not every single part of the product that you need to show that works, but it's that one critical scientific standard that people need to have the confidence

on. Right. So I think it's very tempting when you look at a medical device in general. which is there's just so many different distances, and so many different parts of the product that you have to optimize on since day one, just because you know that there's every single part that has to work really well together. But often when you start putting the picture about, okay, what is truly unique about the product that you do,

you can distill it to me a core few things, and that's the only things that you have to focus on. I think all your efforts should go towards those key things that as of now, no one's been able to show before. And I think if you give a glimpse and enough data backing or knowledge behind an effort, behind me to demonstrate that is actually possible. And that's the one piece that people still have a question mark on, everything else will fall into these. Right. And I think there's a lot of

companies that actually made that mistake in our mind, which is it just weighs a ton of capital and they end up building every single part of the product. I'd say they focus on a beautiful app, which is very flashy, right? But ultimately, the underlying true innovation, what puts your innovation or your product in a different level playing field as everyone else, is that you. is one crucial piece of innovation, which is the far that you should be focusing on us. So I think probably the combination of those two things, is just really focus on the one thing,

and then just try to be as resourceful and we possibly can. Clearly to like the early SpaceX days, they were like, what the key feature that we have to prove in order to get a NASA contract while it's the validity of the rocket, nothing else. We're going to focus all of our efforts on lift, and that's basically what they did. I think the other thing that I want to add is that there is a misconcession in MedTech

where you can't iterate as fast as software. Obviously, there are some limitation, but you can definitely do things to work as fast as possible, depending on what medical device class we end up in. If you're putting like a stent, it's psyche more difficult, but there are definitely ways you can iterate faster. but in our case, work as to medical device in the US and it has to be in Europe.

But some of the stuff that when you did on a practical point of view to accelerate development is like leaching everyone in the same building. And that's something that usually hasn't been done before because in traditional software companies, you've got software engineers and it's easy they'll work from desk, basically.

But if you have like companies which have multiple different fields, which include scientists, which include material scientists, electrical engineers, they would usually be in different environments and we're like the way we can reduce these iteration cycles

and essentially move fast and break things as fast as possible is to put everyone in the same building so they can chat to each other and instead of having to go from like across the city go from one building to another and stuff like this, you don't have to do this.

You can literally like go from one floor to the other and just close that iteration need. Yeah, I'm glad you brought it up because I think that is a very common misconception is this idea that, well, in MetTech, it's so different. You can't build MVP's. It's a slower iteration process.

And don't get me wrong, there's some truth to some of that. But if you fall into that, what I think is in misconception, right? You just gravitate towards not looking for those levers, right, to potentially pull. And it sounds like you guys have found one and trying to bring a lot of those cross-functional expertise

in the same building. But Ren, you touched on something that's interesting, too, because I think a lot of, we talk about this a lot on medsiders, this idea, like, as you're pushing your startup boulder up the mountains, there's all these milestones that you're targeting. And if you can technically break those milestones down into even smaller milestones. And I think the key, as you mentioned, though, is as you look towards that next near term milestone to de-risk your company, you're not to be able to tackle every one of them, right? So the crucial aspect there is to identify the most important, the highest risks, right? And of the belief. that that speaks to how in court it is to be talking to a lot of different stakeholders to help identify what are those top risks that they're evaluating or that they're that that that tend to surface a lot right in a lot of those conversations and some of those stakeholders could be investors right some of them could be in users etc but usually it's only through a lot of conversations and discussions that those key crucial kind of risks or hurdles usually are identified do you guys agree with that Yeah, for sure.

And ultimately, especially the early stages, even the way that you actually explain what the critical risks of the businesses are, as you start speaking with critical straightforwarders, that actually transpons in the narrative that explains why you're choosing those and milestones that are pivotal to show inflection

across the development, lifestyle, all the product itself. And again, initially, we got so many things wrong, to be honest, as we saw that even the way that we were just showing and just demonstrate getting progress towards building a product like the one we're building today, or some of the key inflection once we're working towards, actually it turns out that probably one of the things that we have to do,

focusing on in the short term. So I think definitely just like constantly trying to close that iteration cycle, speaking to customers, investors, and also even people they actually just want to bring on board, being able to constantly resign what are the key milestones that you're working towards, if you're actually always working on the highest priority things, on the high-st-risk elements, and that's where you're prioritizing first, I think is not to be part of one of the challenges of medical last building.

Yeah, yeah. Let's talk about stealth, right? I mentioned this earlier, Sava kind of came out of stealth after a fairly extensive period of time. That doesn't mean that you weren't having a lot of these discussions, right? Yeah, in the scenes, a lot of building going on over that period of time. But what are you general thoughts around staying in under the radar, in stealth mode, versus building in public, which has become a lot more popular, maybe in other sectors or other verticals per se, but becoming a lot more popular. How did you weigh that decision?

Because I'm sure you probably could have gone public right earlier on what you were building. But walk us through that process. I think one way to frame when to go public or not, it's where do you think, how do you think the journey from inception of the company to release of the first product, how do you think that curve looks like?

If you think that curves is like linear, then in the end, you can pretty much predict one to the public. But if it's like in Metac and usually in Metac, it's highly non-linear, in the sense that it's a lot of R&D, it's a lot of figuring things out. And at this point, you're not sure

what you're trying to do will take you two years, will it take you four years. You can have an estimate and I suppose some entrepreneurialism might be better than others at predicting this. but overall it's way more difficult because that system is non-linear

so I think in there are a couple of ways to look at it but here the other way I'm looking at it as we chose a moment to come out of stealth because now our route to market and to launching the product is way more of a linear path than it

has ever been basically because we managed to de-risk the technologies to basically be meeting the muscles that we've been chatting about earlier. Yeah. That's good thought. Yeah.

So in essence, what I'm hearing from you is, and it's going to be nuanced, depending on kind of what you're building, but being mindful or thoughtful about what's that inflection point where you can tell a more definitive story around what you're building. Because if you're still very much, whatever you're working on is still very much a science project,

probably doesn't make a ton of sense to start talking about a public. But if there is, at some point, there's going to be some sort of inflection, right, where you can come out. the public, it's going to be different, right, depending on, again, what you're building. But it sounds like just being mindful of that earlier on is this most important here. Yeah, for sure, I think. Another way to even look at it is that there's a period of especially very complicated

bonnaps where there's a ton of scientific, just risk-layered dating early on, right? And that is completely unpredictable. You know, you think it's not take X amount of time, but sometimes you figure something out that changes the way you actually go about it in terms of the battle. sometimes there's something unknown that happens that actually is a big stumbling book and the actual prediction of how long is actually taking the figure set of things out is very difficult so you just have to be patient. I think there's a lot of benefit in just not being completely dealing in public to be able

to just align internally with the early stage backers that are big believers that it is going to be a very challenging project. It is going to take a lot of time to actually niche this or go over the scientific phase of development, but then wants to see that you're really exiting that. everything starts to become more predictable and the path starts to become linear

like Ralph said I think that's one probably the white moment to come out of stealth is because there's definitely benefits of being out of stuff there's so much inbound there's so much excitement

that you start to feel it becomes much easier even recruit and it becomes much easier to start conversations with investors a lot of these things actually is a lot of benefit

but obviously the flip side of that is that the expectations become way more accountable what you do is it right and in the early stages of science It's actually, it's very difficult to be able to be very apprehension. It's just due to the nature of building something that's never being outful. Yep, yeah.

Those are all really great point. 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 Renéner. Ryan, CEO of Cala Health, Nadine Miarid, CEO of CVRX, and so many others. As a premium member, you'll get to join live interviews with these incredible medical

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