Ameera Patel, CEO at TidalSense: TidalSense diagnoses lung disease in under 4 minutes

0:00Hello and welcome back to Skating Europe Show. I'm Sid Jules and today on the show we have Dr. Ameera Patel who is the CEO of a very cool company, Tidal Sense, Cambridge-based company solving a very important problem. Thank you for joining me today. How are you doing? Thanks for having me on the show. It is my absolute pleasure. Last week you announced a$19 million round. Before we get into the round, can you give a bit of context, a bit of background about what Tidal Sense is, what you've built and what problem you're really solving? Yes, TidalSense is a respiratory technology company focusing on diagnosis of what's called chronic obstructive pulmonary diseases.

0:36COPD is the first area we're working in, which is a really, really, I'd say, understudied problem for the prevalence. We're talking about 10 % of our population. And what we're trying to do is build diagnostic technologies that can be used by anyone in the world at the point at which they present. And, you know, I read in the press release that this is like, this is an area or an industry where the testing hasn't been updated, I think, since like the 1840s. Is that right? Yeah. So the spirometry, which is the gold standard for diagnosis, stems from the 1800s. So the thesis on spirometry was published in 1846, which is crazy, right?

1:20What it's measuring is flow and volume, which is quite easy to measure with analog methods. And if you look at what we're doing, we've taken a CO2 sensor, which CO2 sensors were only miniaturized in the 1980s, and we've developed that sensing capability for respiratory diagnosis. And why has it taken so long? You know, given that this is such a prevalent problem that so many people suffer from, people are dying from it, the testing hasn't been updated in such a long time. Why has this not happened until now? Well, I mean, as I said, like CO2 sensors were only militarized in the 80s, right? So there was a lot of technology development that's required to get a CO2 sensor that can do respiratory diagnosis.

2:02It was only in the 1990s that the first papers were published that showed that you can get a obstructive respiratory diagnostic signal from CO2. But actually, those sensors and the capabilities of those sensors were not good enough at that time to do respiratory diagnosis. So what you actually have to do with the sensing capabilities is be able to measure very quickly, very accurately across the entire range of CO2 concentrations that occur in normal breath. And that's something that we solved and have then built the diagnostic technology off the back of that. And what specifically have you built?

2:41Well, it's a combination of two things. We've got the hardware, which is a handheld physical device that the patient just breathes through normally. and with that diagnostic software. We had to really think about what the problem is for healthcare providers that we're solving and then build the technology around the use case that's needed to actually have impact. That's really important because I think it's something that a lot of companies don't do. They try and sell the technology to the healthcare provider and actually we're not selling a diagnostic test. we're selling better patient experience and improve operational efficiency interesting yeah yeah it's like a it's being built like a like a more classic tech product as opposed to a more like medical device right you're thinking about the end users and their experience as opposed to just like building the technology itself that's really interesting can you talk about where what stage of development you're at because i think it's already being used in some places already in the nhs is that right that's right so we are a regulated device as a medical device that's doing diagnosis you have to go through the medical device regulations which actually takes a long time so we got our regulatory certification in march last year and that's at class 2a so diagnostic devices have to be certified to a certain standard which is what class 2a means and we launched into the nhs in september last year and since then it's been it's been pretty exciting actually really interesting early findings from those initial deployments which will be published later in the year and the demand has been kind of overwhelming actually oh amazing can you talk a bit a bit about that like how does demand in your business work because i guess you know when you're kind of deploying to the nhs what does that actually look like well i mean there's different ways of quantifying demand we get crazy numbers of messages from patients trying to like express how bad their journey has been to get a diagnosis and how much they want to support us.

4:45I mean, that's constant. But we also have had inbound from over 60 countries because it is actually a global problem. A lot of countries have no access to testing because spirometry fundamentally requires skilled operators, which most of the world don't have access to, equipment that needs maintaining, calibrating, and specialist interpretation of the test. Interesting. Okay. you talk about I guess like people reaching out with their own personal problems their own personal experience can you touch a bit on your own personal journey that kind of led you to to to get into title sense yes I mean I have I've been pretty convinced I've had asthma since I was a kid but there was just repeated present like I'd go to the GP multiple times and never got a diagnostic test.

5:39And I get to uni and I'm playing sport, really struggling to play sport, going back to the GP. There's no access to diagnostic testing in my GP practice. So they're like, well, you know, you might have asthma, go home, try this blue inhaler. A lot of patients just feel like they're wasting clinicians time, right? When you're constantly being sent away. This was my mindset. I'm like, I don't want to waste any more healthcare resource. So I'm just going to, like a GP doesn't think it's a big deal so i'm gonna leave it and then fast forward to my mid to late 20s and i had some catastrophic asthma attacks that almost killed me and that's the point at which i'm that's the point at which i got diagnosed and even if you look at copd patients a quarter of them are being diagnosed in the uk after their first hospital admission wow that's crazy that's insane i mean Yeah.

6:34The access is just really poor. I mean, just think about the amount we spend, you know, on the healthcare in this country. And the access is still really poor across most of the UK. That's insane. And I think it looks like what you've done remarkably quickly is, maybe I've got this wrong, but it looks like you've been able to kind of get it out into the NHS quite quickly, roll it out quite quickly. I think we're in a few different regions already. I imagine this is probably like such a slow world to operate in, both in the creation of doing both hardware, medical devices, software at the same time, getting it, you know, the official regulations or certifications, then rolling it out.

7:14How has that journey been? And how have you been able to move what looks like from the outside relatively quickly? Yeah, I'm glad we made it look smooth and quick. It is actually, as you say, it's a really long process because things don't change very quickly in medicine. When technology has come into the market, you've got to convince clinicians that they perform in the way that you say they perform. So you've got, even after regulatory clearance, this huge, long array of diagnostic accuracy studies and real-world evaluations you've got to carry out. You've got to work out how it fits in the pathway.

7:48You've got to work out who's going to pay for it. What are the incentives? You see this huge graveyard of devices, these amazing devices that really have huge impact on patients that never make it because of some weird payment incentive, right? Where a clinician like in the US isn't making as much money by using the cool technology. So it never makes it out there. So it is a really long journey. It does take a long time. what we did that I think is the really key thing was we focused on the actual problem that what we knew our customer which is the clinician was having and built the product around that and a lot of people don't do that in the healthcare space is not about the technology at the end of the day what we've done is built something that is just relaxed breathing for the patient which means that almost every patient can actually do the test.

8:41It takes as little as five minutes. Actually, the median testing time in the first services has been three minutes, 44 seconds, which is insane when you think about sperometry requiring an hour. And we use machine learning to automate the interpretation, which means like the way I think about it is we've trained the models on specialist clinician labels, like the specialists have labeled the data and we've then encoded that knowledge into a machine learning model, which automates interpretation. So the way I like to think about it is when you scale that to new countries that don't have that specialist training, you've kind of encoded it within the machine learning models.

9:23Oh, that's really interesting. You're like, you're bringing the value or the expertise from this initial market and you're able to take it to other markets because you've already trained those guns. That's interesting. And so, yeah, you're massively saving time. It's more accurate than spirometers. So I guess that's why you're thinking about the user experience, right? Both from the clinician's point of view and from the end user, easy to do, faster and more accurate. Can we talk a bit about the raise itself then? We've raised this$19 million. What enabled that? What unlocked this round at this point in time?

9:54That's a really interesting question. You know, if you look back through our journey from founding all the way to now. Very early years, six years was hardware development, iterating on the hardware, getting it to work, getting it to the point where we could regulate it, I mean, solve the technical problems. No VCs want to invest at that point in hardware companies that have that level of risk. So it takes years to bootstrap on effectively public funded money. And we finally got to the stage where we de-risked sufficiently to raise a big enough round. And that meant regulatory clearance, initial commercial traction, building something that users really, really loved.

10:37That's kind of what allowed us to raise the money. Amazing. And can we talk about some of those investors? Because I think the lead investor cross-border impact ventures, they are North, are they US? I know they're definitely North American. What does that signify? Does that signify potential? Are you looking into that market now? Is that where your eyes are? So, you know, tell me about them. How do they get involved? What do they see the value for? What does that mean for the business? We were really fortunate in being able to choose our investors. Amazing. Which is not a luxury that everyone has.

11:10For us, Cross Border, we're able to take a long-term global view. They had the same ambition that we have, which is to scale this globally, to have global impact and solve the diagnostic problem. even in low middle income countries where access is almost zero and that was really important for us you pick up on the point of north american you're right that is a market we're interested in it is the biggest the us is the biggest market um for us although it's difficult to ignore china there are 100 million patients with copd in china of which it's the 90 million are undiagnosed so So, you know, we are looking now at scaling this across at least a number of key strategic markets.

11:54But beyond that, we want to make it available to every country. Is there, you know, you're in three or four regions in the UK now. Is there a level of kind of market saturation in the UK you want to get to before you start thinking about either North America or China? Or are you already thinking about what that market entry could look like? Interesting question. I mean, the thing is market entry for a medical device company in any of these markets involves regulatory certification, which takes a long time. So you've got to kind of start planning that many years before you want to actually enter the market.

12:30So we're starting that work now. There's a lot of regulatory paperwork that the FDA requires to get to U.S. market entry. so hopefully by the time we get to us market entry we will have reached the saturation point that we're targeting in the uk market and we use that as the full scale yeah it's interesting you've got such a longer timeline than a classic tech company it's like a stats adverts or ai product that can just like you can always be pulled into new markets just by customers i guess it's very different when you are in a very highly regulated medical space uh the 19 million dollars itself can you talk a bit about what you're going to use that for yeah i mean effectively it's a lot of it's going towards people.

13:10So that's hiring commercial and operations. We've got our core base of R &D team already within Cambridge. So we're not looking to do significant amounts of R &D hiring. And then there's always a portion allocated for regulatory market access. It's always a big chunk of money that a lot of people underestimate for medical device companies. And then clinical evidence. You never stop generating clinical evidence when you're a medical device company. That carries on throughout your lifetime. And you mentioned that you've kind of, you're kind of already gathering some findings from the initial rollout in the NHS.

13:46What's that going to look like? Is that going to look like a specific published paper that you're going to push out towards end of the year? Yeah. There's a couple of key conferences where some of these results are going to be unveiled and then yeah, publications. And what does success look like for those points in time? You know, what would you like to get off the back of those conferences and publications effectively wider commercial acceptance and and rollout i mean that's ultimately the we have we have some really great loyal early adopters and they've been helping us build this operational evidence once we publish that we're expecting demand to go up and that demand will come from is that like trusts regions within the uk Yeah, the UK, but we're also looking at Europe now.

14:33We're looking beyond Europe even. But within the UK, trust, yes, but also integrated care boards. They're the primary mechanism by which we're commercializing the technology. and for you you know you just i was going to ask what's your biggest bottleneck right now you know that you've obviously got the money is it the team do you need to hire better and more people now that you've got more money is it time do you just need more time out in the market to get more evidence of success is it convincing the rest of the world that this is something that is working is worth doing is it regulation like what is the biggest thing that is slowing you down today Such a great question.

15:12It's not one thing, but time is always really important. It takes time to develop the evidence, to publish it, to validate the operational model when you're putting a new diagnostic pathway together, to even optimize the pathway. What does that look like? So it's maximizing savings for the healthcare system. That's definitely one element. um and then and then now that we have now that we have the the money in the bank so to speak we will start hiring amazing and the one final question you've just raised this big round i you know at some point down the line you're probably gonna think about raising another another big round what is going to get you from where you are today to being able to raise that that next round of money to enable you to do even more u.s market entry is the number one thing It's a big market.

16:02You know, the EU medical device regs that we're certified to and the FDA, once you have both, a lot of global markets will accept either or of those certifications. So that's what gives you the foothold, having those two to then scale globally. Amazing. Well, look, congratulations on the round. Congratulations on the success that you've seen. It's going to be super exciting to see the journey from here on out. And keep me informed. You know, I'd love to hear how you're doing. I'd love to see the success that you're enjoying and you're going to continue to enjoy. So, Mary, thank you so much for joining me.

16:35Will do. Thanks for having me.