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Ep18: Elena Mustatea, CEO Bold Health


0:03 Eugene Borukhovich 

Welcome to Digital Therapeutics Edition of Digital Health Today. I’m your host, Eugene Borukhovich.¬†

In the last episode, I had the pleasure of speaking with Jonas Duss, co-founder and US CEO of Kaia Health. During our conversation, Jonas spoke a little bit about a McKinsey report titled “The European Path to Reimbursement for Digital Health Solutions.” I thought the report could come in handy for our European listeners and entrepreneurs; you can find the link to the report in the show notes for that episode.¬†

In this episode, I got to speak with Elena Mustatea, CEO and founder of Bold Health. As with many startups in the health and care industry, Elena went through her own struggles and IBS before starting Bold Health. 

But before we dive in, I met Elena at Frontiers Health Conference in 2018, which is when Bold Health was officially born. Elena struck me as a bold and determined person on a mission to change the landscape for gut health overall. And now, we jump to my conversation with Elena. 

Hi, Elena, welcome to the DTx podcast. Why don’t you tell our listeners a little bit about yourself, your background, and how you got to create this interesting company?

1:19 Elena Mustatea    

Absolutely. Thanks so much, Eugene, for having me. Great seeing you again and being here with your listeners.

My story into digital health starts from when I was little, probably as far as I can remember. Starting school, I started having digestive symptoms of all kinds, especially a lot of abdominal pain, stomach pain, [and] went through dietary changes. I had this lifestyle where I was a very good student, very stressed out about schoolwork and all of that, which I think really affected my digestive system. I grew up in a family where everybody had some form of digestive condition, which I took as normal. I thought this is how humans are. 

But when I grew up and developed what I now know is IBS, in my first job it started really annoying me, because it affected my performance, my quality of life, my ability to be intimate with my partner, and so forth. Then I really wanted to do something about it. So I did cure my IBS, I now feel really good. I haven’t had any issues for probably seven, eight years now. I wanted to do the same for other people who might be living like this and don’t get the care they need and don’t get solutions.¬†

At Bold Health, we develop digital therapies for digestive disease, where we help people self-manage, self-care, self-treat their digestive conditions, starting with IBS, irritable bowel syndrome, and IBD, inflammatory bowel disease. That’s the initial drive on my side. Then I met my co-founder three years ago. He’s a doctor, and he’s very driven to solve patient issues, and chronic illnesses is the biggest cost driver and biggest burden for patients as well. We were both very passionate about solving [inaudible] medical problem for individuals.¬†

I actually come from a business background. After graduating with an economics degree from Dartmouth in the US, I went into management consulting in Dubai, working on a number of Middle Eastern projects around strategic growth. Then I went into investment banking, moved to London with JP Morgan, and spent time in the TMT practice, advising, especially technology companies, around M&A and financing. Getting closer to the technology space, I really loved it, loved the dynamism of it, the fact that I was solving so many of our problems today. 

Then I became an investor with a fund called Atomico, a VC fund based in London started by the Skype co-founder, and was very mission-driven to solve some of the biggest problems and support entrepreneurs, especially European entrepreneurs in doing that. My coverage at Atomico was in part digital health, so I got a chance to look at the “pioneers” of digital therapeutics. The first wave, especially those UK players, many moving to the US, like Sleepio, SilverCloud, Hinge Health. I got a chance to be on the team when we invested in Hinge Health and learned about that journey. Hinge Health has been an inspiration for what we’re doing at Bold Health, so hopefully we can step into their shoes one day in that pathway. It’s very exciting what they achieved in just a few years in the MSK space. We’re hoping to do the same in digestive.

4:44 Eugene Borukhovich 

I’m going to dive back to when you were having the challenges with your health. IT sounds like you were hacking yourself back to health, trying to figure out what works, what doesn’t. When [did] the light bulb [go] off, that you can actually impact people’s lives? With digital therapies, when did it go off? Was it while you were already at Atomico and getting the VC experience and you said, “Well, let me rewind back because it’s now been x years, and let me create something this time”?

5:16 Elena Mustatea    

It was way back, in my first job when I was in consulting. I had a pretty bad lifestyle. I was travelling a lot across time zones, I wasn’t sleeping much, working long hours, going out a lot. I think stress had a say and poor lifestyle; I didn’t even realize. I started my day drinking a diet Coke and thinking that was fine to just put that into my empty stomach. Only when I started having health problems, I [thought] okay, maybe that wasn’t right. What I did then– and I was surprised– I found a detox retreat in Thailand, actually, that does a lot of what we do in our program. It was part behavioral modification, part cognitive therapy, part taking a break– giving my body a break. We would do a lot of yoga, physical exercise, being in the sun, being by the sea– which is very healthy– doing relaxation practices, like massages, having a very clean diet (that probably rejuvenated my microbiome) and lastly, I changed my job. I think that was also another factor, I wasn’t enjoying my job very much. Having that time to take a bit of a break and do something that I’m more passionate about; that’s more the cognitive piece, that’s more the psychological part of the illness.¬†

When you might have a life situation where you’re not very happy, you’ll probably have some sort of back pain or stomach pain and so forth. The lifestyle piece, I gave a shock to my system with really good inputs of exercise, food, sleep, and relaxation. I think yoga also played a big role in that; it gave me the digestive system-friendly yoga and asana that were specially designed to help heal the gut. That completely got rid of everything, that one-week intervention.¬†

But it’s very much the same principles. In the case of irritable bowel, it’s a functional condition, it’s a dysfunction of the gut-brain link, of the nervous system of the gut, the enteric nervous system. So by applying behavioral therapies and relaxation therapies, like deep abdominal breathing, or yoga or hypnotherapy, where you listen to a very deep relaxation exercise, that’s when the nervous system of the gut regulates, and that leads to the function of the gut being regulated. It’s exactly the same principles and mechanisms, which I was lucky to discover by mistake. I thought I was going on holiday to be honest, because I needed a break after my stressful job, and then I actually restarted my health.¬†

With digital therapeutics, [I] rediscovered the same principles and realized this is the scientific framework that is proven, especially through cognitive behavioral therapy. Cognitive behavioral therapy for IBS is a multi modular framework in an integrative care approach. It doesn’t just look at emotions or stress. It also does certain exercises, lifestyle modification, education, all of it. It’s this care package that we learned is also science-based, is proven in clinical trials, is considered gold standard, [and] is accepted by doctors. We weren’t just talking about some “woo woo” therapy, some alternative therapy that would be really hard to accept in the market. It was something that we could go at as a scientific framework and also something that’s been done, especially in the behavioral mental health space. There was that acceptance of digital therapeutics and early pathway of success. All of that combined inspired us to solve this problem in digestive health.

9:07 Eugene Borukhovich 

Part of this podcast is getting to know the people, the trailblazers, like yourself. You mentioned you went to Atomico and were part of funding Hinge Health, so DTx as a term was already established– the DTA was already on the scene. How much did the Atomico experience give you to start the company [and] get the initial funds to prove certain milestones? Talk to me a little bit about that funding mechanism.

9:40 Elena Mustatea    

Before that, if I may make a very slight digression. When I was looking at Hinge Health, even though digital therapeutics existed as a term, Hinge Health never called themselves (or not when we invested) digital therapeutics, because they said in the end, the patient heals themselves [through] their own therapy. They have to actively do things. They have to do exercises, physical exercises, go through the CBT in the program, talk to their coach. It’s not this magic pill that gets inserted somewhere in your system and you’re magically better. I really liked that idea that you create the digital care pathway and provide a structure and the content that the patient then takes to become the active healing ingredient. It’s that self-care pathway that we enable. I really, really like that. There is this alternative, your pure play digital therapeutics; you’re the mechanism of action, and you get an FDA stamp on it, and that’s it. But it’s not [that] easy– the patient [is] that active force in the whole care process.¬†

Besides that, speaking of fundraising, in some ways, I had to relearn everything from scratch to become an entrepreneur. I was very lucky that my co-founder, who’s an experienced entrepreneur, he’s been doing startups since he was 12. He’s done multiple digital health startups, he has built many digital products, he’s very product-oriented. I was very lucky to be with him, who had the straight intelligence of having done it before, and I had the theoretical background, doing some business school courses and all the VC theory– what startups should do and what entrepreneurs should do. I would say 50% of that is theory. There was some inspiration I got. For example, what are meaningful KPIs, what is meaningful growth trajectory, what [are] meaningful financial projections you should aim for and grow? But besides that, I had to learn from scratch.¬†

My network and knowledge was very much Series A onwards, so at a point where you already have product-to-market fit, where you have a developed product that is selling that you have confidence that it’s gonna make it. And you require much more capital to scale that model that already works. Whereas we started completely from scratch. I had to learn a lot about the angel landscape, early stage grant journeys, [and] convince a lot of early stage investors that had very different investment drivers than [the] Series A onwards that we did at Atomico. It was helpful from this stage onwards, where we enter product-to-market fit and growth. But so far, we had to make it happen, we had to hustle for the capital we went after, and GI wasn’t much of an established segment within digital health and health tech.¬†

Being early movers, there has been an element of convincing people, making it the condition area that deserves the attention and making the kind of category that deserves to be because it’s highly prevalent. We know 75% of the population have some form of GI symptom in any given week, and about 30% have a diagnosable long-term digestive condition, with IBS affecting about 15% of the population. Massive conditions, very common, very distressing, to large productivity losses associated with it, [and] large distress; a lot of mental health burden is associated with digestive discomfort and illness. But it’s a bit of a hidden topic, it’s a bit taboo. We know our families have all sorts of these digestive problems, but we don’t realize the rest of the world does.¬†

So the fundraising journey has been relatively slow. But that actually helped us because we only raised as much as we needed at every step of the way. We managed to be extremely capital efficient, and we had a model where we had a global team, so we tapped into the best, cheapest talent, with a base starting in London. We worked with developers from around the world– from Romania, from Nigeria, where my co-founder is from, from the Philippines, where he studied, and so forth. Also, we’ve had advisors and key opinion leaders; because we were early stage, they never wanted us to pay them or anything like that, but they brought huge value to us. We’ve been lucky, I think, with our fundraising journey, but it definitely hasn’t been easy or straightforward. Only now, digital therapeutics, maybe it’s entering the hype stage, but I think it very much matters how you position yourself.

14:31 Eugene Borukhovich    

You mentioned earlier [that] GI was not a sexy topic. There was not much knowledge about [it]. You started the company sometime in 2018, so in a short amount of time, I think GI came to light; there are some companies like Mahana and a few others. So [three years later], is GI’s– for lack of a better term– “sexiness” helping? Now there are some competitors. Maybe there are different approaches to all of this, so maybe you can [compare and] contrast a bit.

15:05 Elena Mustatea    

I think GI is going to happen soon enough, so in two, three years’ time, we’re going to have large adoption and accessibility for GI care, and some of the players are going to mature, including ourselves. We benefited from [being] one of the very, very early players.¬†

Two things; the microbiome space has been around for a while, but it hasn’t reached scientific evidence, it hasn’t been proven. There’s been a lot of money poured into it, potentially one day things will line up, but for now, we don’t have very good evidence of how it works. If we’re applying a probiotic or other things, [it’s] to improve our general health, not just gut health. Microbiome was one that opened the gates, I would say, and then an early player out of Germany, Cara Care, brought the topic in the fundraising circles and conferences and so forth. Actually, some of our investors invested in us because they [did] due diligence [of] Cara Care [and] maybe they didn’t build enough conviction in that company. But when they heard about our model, and how we think about it, and our solution, they were like, okay, this is actually the right path. We know this market is significant, the market needs are significant and unmet, very prevalent and so forth, so it will definitely become a big area. When they met us, they had confidence to finally invest.¬†

In terms of other players, you will have a few that are taking the FDA pathway within digital therapeutics. Similarly, CBT-based or hypnotherapy-based solutions that you package into pure digital intervention that you then take to the FDA as a typically Class 2 device. That’s the pathway that most of our competitors are taking. That’s Mahana [and] metaMe Health. Pear Therapeutics also has in their pipeline a GI solution for IBS, but I’m not sure at which point they’re going to bring it to market. But all of these are in the FDA process. Mahana just announced their FDA approval, soon they’ll be in the market likely, taking more of the prescription pathway.¬†

As I explained for Hinge Health, it’s more of a digital care pathway. CBT itself is not typically an FDA-approved intervention, or therapists are not FDA approved. We say this is enforcement discretion; people should be able to access this self-management tool [inaudible]. For now, we’re not going [down] that FDA pathway. But quickly, things are moving in the space.

17:42 Eugene Borukhovich    

It’s great that you contrasted some of the players and components. I’m curious, because for our listeners, I think digital therapeutic might sound [like] “digital” into “therapeutic.” What is that experience like? Maybe walk us through if you are an end consumer/patient.

18:05 Elena Mustatea    

What we did was to partner with a clinician at the University of Pennsylvania, Dr. Melissa Hunt, who developed a light touch CBT program for IBS. She’s a psychologist, and she was treating people for depression, anxiety, and she saw this pattern that almost everybody was complaining [about] gut issues. She saw that link between your gut and your brain, and between gut disease and brain health, and behavioral issues, and distress. That’s how she developed a number of interventions: one for IBS, one for IBD, and some others in her work. And the good thing about Dr. Hunt’s work is that the CBT interventions develop [are] low intensity, so it can be very much a self-care, self-driven program, where the patient goes through the content, the different things they have to do, the education, and don’t need so much therapist guidance. This is very good from a digital perspective, because you can more easily translate it into a fully digital intervention, which is what we did.

We considered for a long time whether to add a coach to the journey, or some sort of human component. But we said let’s first prove that as a digital intervention, it can be effective, and let’s see how effective it is (for how many people it works) and then decide whether to add more human elements and try to make a very scalable, very digital self-driven program. What we did was to create a digital assistant, a virtual coach for IBS, if you want to call it, that is meant to be a bit like a specialist nurse in IBS that understands this program of care and can guide the patient through the steps on the care journey.¬†

We onboard users through a series of chatbot conversations, videos, animations, audio, so a very multimedia experience. The patient comes to the app, we assess their state, and we have this baseline data of how they are faring from a GI symptoms perspective. What’s their mental health like, what’s their quality of life, and a few other scores. Once we do that, we put them through a program that is a bit individualized, personalized to their symptoms and the type of IBS they have.

Then we have six modules corresponding to six weeks of a CBT program. Each module is subdivided in sessions that you can do at different times during the week. Again, very interactive between the chatbot and audio/video. That teaches the CBT model of the link between emotions, thoughts, and behaviors that may or may not impact IBS symptoms, and teaches the patient to identify negative patterns that could make them be unwell, and reverse those for a better mental state and physical state. You go through these weekly modules for six weeks. 

Then there’s daily exercises. At the beginning of the program, patients are asked to create a program of care that fits around their schedule, so that every day they build in a tool, an exercise, a practice, that regulates the gut-brain link or relaxes the nervous system, has the guts to regulate function. These are exercises being taught across the CBT program through each module: things like progressive muscle relaxation, or how to do IBS-specific yoga exercises, or breathing and so forth. Then they start applying that progressively, day by day, and doing even cognitive exercises, [like] certain journaling techniques. That’s over six weeks, it’s a pretty intensive program. But it is flexible around the patient’s schedule.¬†

Then we have a maintenance program. At the maintenance stage, that’s a long-term program. We know IBS is a long-term condition, [so] we do aim to get people– after those six weeks– from severe IBS to mild or moderate, functional, and doing very well. But they might still need some support. We obviously have a community and support in the app. They can access that, but they can continue to use the tools to do the daily practices, or if they want, weekly practices. To give a parallel, the way you would use a mindfulness app, you would also use the app to do daily exercises, like 10 minutes of hypnotherapy that gets you in a really good mind and body state around gut sensitivities and symptoms. There’s that initial journey, plus the maintenance.

22:47 Eugene Borukhovich    

It’s interesting, because you talked about self-care, but still the need [for] guides and coaches. You guys are not taking today a PTD, or prescription DTx route, so where do you see the doctors, nurses, and even health coaches in your model, longer term?

23:08 Elena Mustatea    

Longer term, it will depend on the system where we deploy the solution. It will be a bit on a case-by-case basis. For example, we’re working with the NHS in the UK, where we can create a supported program with NHS staff. Specifically, there’s the IOP program for increasing access to psychological therapies, there is an IBS track with CBT for IBS, where they have human coaches or trained psychologists, counsellors to support patients with this type of intervention. Then the patient will use our app for self-management, and they would have some form of human support– maybe a 10-minute check in every two weeks with the assigned coach/counsellor. That’s more on the neurotherapy side of things.

As I said, our intervention is low intensity and light touch from a human intervention perspective, it doesn’t need that much. That said, a health coach can be valuable in keeping the patient engaged, keeping them motivated to stay on the journey, and so forth. That is something we do plan to integrate, especially for our B2B model for serving employer populations or health plan populations.¬†

Now in terms of clinicians, nurses, and so forth, that’s where we look more at the prescription pathway. In the NHS, again, we’re looking more at primary care referrals and prescription, where we expect GPs to prescribe [inaudible], and there we are getting integrated into the specific systems or EHR platforms they have, and prescription platforms.¬†

In a very fragmented system like the US, this is less obvious and straightforward. So whenever we do an integration with the health plan or an employer, we are going to integrate within their possible system. 

But the good news is we don’t need a clinician or a nurse necessarily prescribing or [being] part of the care pathway. It would be nice. We know that evidence shows that when a doctor prescribes digital therapeutics, it has better engagement, and with that, better outcomes. We’re going to work on that, but it’s not necessary.¬†

First of all, we’re going direct-to-patient. Whether that is through their employer, we would still market to get them, the patient, the sufferer, to download the app. At the moment [we’re] also doing B2C. We’re present in the app store, [and] we’ve gotten to over 10,000 organic users, simply through discovering us in the app store. Then [in the] NHS, we’re already testing the more clinician-based referral and recommendation at the moment, [and] soon prescription, once we get on the more official digital formularies. It is definitely part of the journey, and we adapt to the system and the payer/the client setting.

26:03 Eugene Borukhovich    

Super interesting. It’s still [a] relatively young stage as a company, you’re still discovering. You’ve built a product that’s clinically validated, based on your experiences, but also science-backed, as you talked about, with Melissa Hunt’s work. What was your original hypothesis on the business model? You mentioned direct to consumer with 10,000 downloads, the NHS one-payer system, and then you mentioned employers. What was your original hypothesis when you started the company, and how has it evolved your thinking to date?

26:38 Elena Mustatea    

It was exactly the same. So we see in the end what we do is consumer health, but the way you reach the consumer/the patient is through different distribution channels along the care pathway. I think it also depends very much on [the] condition. Because we started in IBS, and the nature of IBS is that it’s partly managed in the medical system, but a lot of it is self-management, over-the-counter medicine, people doing self-discovery of all sorts of solutions (from alternative, to probiotics, to drugs and painkillers). So in that sense, we’ve always seen IBS as having some direct consumer play.¬†

However, our business development focus was always on B2B2C, because we want to reach populations at scale. We knew that [we] want[ed] broad coverage of a population so that it’s more accessible for patients at no cost or at low cost. We’re always going to work on that. I guess the NHS is our biggest market where we’re currently doing that. We are now working with the primary care association network with 5.5 million lives coverage, so [we’re] currently deploying at that population level, and we want to do that across many other settings. That’s the B2B model.¬†

But in the end, it might be through employers, benefits programs, private insurers, or health systems, or any other system where patients are and are seeking care for this condition. We’re focused on getting coverage in those respective distribution channels.¬†

Now, in terms of the benefit of putting an app like ours in a B2C setting, giving it out to patients is significant, because it allowed us to test with thousands, now tens of thousands of users and patients in the real world and see how they use the app: see what their needs are, what their questions are, what other features we need to build or remove to simplify the care journey. It allowed us to not only run clinical trials– and we just published our first RCT results, actually, it’s in preprint– but we have really, really positive results from our first study. We ran a completely virtual trial.¬†

We were out there with patients from day one, [and] that allowed us to build a brand that allowed us to build a followership and volumes in the market, and data that allowed us to build our product and iterate and make it the best GI digital therapeutic in the market. So whenever Mahana comes with their FDA approval or others, their real-life experience will be limited. Also. the ability to iterate will be limited because you have a relatively fixed FDA-approved product, whereas we’ve been there with patients and really listening to users and so forth. That’s why B2C is really important, and now we’re showing that people get so much value that they’re paying for the program, so we also have a really high payment conversion rate. We’re learning it really is a huge need, it’s an unmet need that people even [in] B2C would pay for, which is quite rare in healthcare. So it allows us to do a lot of experiments and have a lot of learnings, but ultimately we are going for B2B.¬†

One more thing I’m going to say, on this comment on it depends on the condition area. For inflammatory bowel disease, for example, it’s a much more, let’s say in the prescription space of things; it has prescription drugs. It’s a life-threatening condition. There’s no joke how you treat patients and what you give them. There it makes more sense to have, for example, a more regulated product and make it doctor prescribed. That becomes more of a B2B model. So it depends.

30:32 Eugene Borukhovich    

It’s time for a question from my journalistic partner on this podcast, Brian Dolan, who is the founder of Exits & Outcomes, and as I like to call him, the digital health detective. Let’s see what question Brian has for our guest today.

30:45 Brian Dolan    

Okay, here’s my question. What is your pricing strategy for remedy? Do you base it on current pharmaceutical therapies’ pricing? Do you base it on replacing the work that a healthcare provider would be doing without your digital therapeutic? Or do you price it some other way?

31:01 Elena Mustatea    

Thanks, Brian. This is the golden question following Brian’s work around pricing in digital therapeutics.¬†

I’d say there’s two main aspects to pricing and what we do. One is how much value can you generate that is profitable for the payer. So providing ROI to any payer you serve. Pricing is adjusted to that and to the context, and then benchmarking with the market. So if we came up with $10,000 pricing because we have the most unique, or the world’s first CBT-based program for IBS and whatnot, that doesn’t mean it would sell, because someone else will have it at $2,000 or $200. You always have to play within the limitations of the market.¬†

But I think pricing work is continuous and based on each setting. So the NHS will have different cost structures and different therapy costs for the comparison to the real-world, face-to-face therapy or to the drugs. Therefore, our pricing will have to be system-adapted and still provide an ROI to the NHS. They will always want to see cost savings; even if you dramatically improve patient care, you have to prove the cost saving. Same in the United States with employers and health plans. It’s about providing that ROI.¬†

With that in mind, pricing for DTx tends to be somewhere between $500 to $1,000, maybe a bit over $1,000, depending on the level of support. Our program for now [has] very limited support because it is very effective in digital format. It’s low intensity, as I explained, so therefore, we, expect on an aggregate basis to be somewhere between $500 and $1,000, depending on the setup and the level of support.¬†

But then what we’re going to do, realistically, is run health economics and analyses on every deployment. We’ll look at claims data, we’ll look at productivity gains, so that we can show that whatever pricing we have, it will generate savings, it will be value additive to the organization.¬†

Lastly, in terms of a pricing model, even though there’s population-based pricing, there’s usage pricing, we gravitate towards usage pricing. Per active user, per month, for example, but somehow front-loaded, because the nature of the program is that it is most important and most effective, most impactful in the first two to three months. Therefore, we would have a higher pricing around $150 in the first three months, and then for the maintenance program, you’ll have a much lower price for that ongoing journey. Then I think about it as an aggregate, landing per user, depending on the number of weeks, somewhere between $500 to $1,500, depending [on] how engaged they are in the program.

33:58 Eugene Borukhovich    

To follow on Brian’s question– and you alluded to this earlier that you have a pretty good conversion in your direct-to-consumer model– as a consumer, once I convert, what am I paying as a consumer?

34:13 Elena Mustatea    

We maintain, for now, a model that’s recognizable in the app stores, so these typical subscriptions where you can pay for a monthly, or three-month package, or for a year of access. We nudge people towards the year program, but someone can sign up. It’s a subscription.¬†

We are changing that soon. Right now, we’re still testing, and at the moment, we’re working on making the app as accessible as possible for the broader public. Then the real pricing model will be at the B2B level where all the costs will be built in and so forth. At the moment we’re trying to make it price accessible, especially given COVID. Studies came out that a minimum 15%– 13% to 15%– of GI populations are seeing an increase in their symptoms. We know the need is becoming more acute now, so we like to make it as accessible as possible.

35:08 Eugene Borukhovich    

So I have a feeling I’ll know the answer to this based on our discussion already. There are a number of molecular therapies available– I don’t know the effectiveness of them, but Alosetron, Rifaximin– but companies like yourself are obviously designing consumer experiences with a combination of cognitive behavioral therapy and human beings. I’ve been asking this question, where do you see pharma in all of this? Will companies like yourself say, “well, to augment this digital therapy, you may need to take a certain pill”? Or do you see yourself bought out in 3, 5, 7, whatever years, as a companion to a molecule?¬†

35:56 Elena Mustatea    

I think what we do is a category of its own. There is a play for complementary, additive effect on disease management and outcomes, where both the drug therapy and the digital therapeutics might have a level of efficacy and outcome. But I wouldn’t see what we do [as] a companion where you just get some data, get some patient information, do some remote monitoring, and that’s it. No, we’re very, very focused on therapeutic impact and outcomes.¬†

I’d say it depends on [the] condition area. So in something like IBS, we pretty much replace drug therapy. The intervention is so effective for such a large percentage of the population with such effect, that most likely patients will get off drugs or will use them less on a more acute basis, and so forth. We know the effects are maintained as well; [over] three months, six months, three years even, we’ve seen the positive effect remaining for the patients under these interventions.¬†

But in something like IBD, there’s more of a place for both the drug therapy and the digital therapeutic to act together. [With] something like IBD, CBT programs can help with symptom management when improving quality of life, and equip patients to better live with their IBD through patient education [and] tracking and remote monitoring, which you will always do through a digital therapeutic. We can act on symptoms like pain, fatigue, urgency, depression/anxiety, reducing rates there in mental health. You affect certain condition outcomes and symptoms, and that helps with the general program of care that the patient might be under.¬†

There’s definitely a place for collaboration. We also know the highest results are together between drugs and behavioral therapy. There’s a study in IBS, for example, that showed that CBT alone has 70% efficacy, but if you added standard of care drugs, it went to 80% efficacy, so drugs brought in a bit of a margin, but why not? You definitely want to combine if that’s possible.¬†

We are discussing [with] a number of pharma companies. We’re open for collaboration; we’re looking for co-development partners. It’s based on condition, where that makes more or less sense to combine with pharma therapy.¬†

Ultimately, my vision is that digital therapeutics will become a pipeline of digital drugs that pharma will have stem cell therapy, and molecular therapy, therapeutics and then digital therapeutics and so forth. That will become integrated in this [pool] of therapeutic options. It won’t be just a companion. I think there’s so much more potential than that.

38:46 Eugene Borukhovich    

I predicted your answer. Thank you. Finally, entrepreneurship is not easy. What is your why? What gets you up every morning?

38:56 Elena Mustatea    

I’d say it’s a bit of an inherent dissatisfaction with how people are currently treated. When I learned about functional conditions– of which IBS is one, and we have migraine and pain syndromes, and endometriosis and autoimmune– there’s a very high degree of disability, of distress, of comorbid mental health problems, and these are really impacting people’s lives and sometimes render them unable to work, unable to care for their family, [or] to do what they love. Then we tell all these people, in the standard medical system, we can’t do much for you. Or, “you’re fine, you’re not gonna die.” We don’t know what’s wrong with you, all your labs come back normal, and then the person goes home and they’re desperate, and they don’t know what to do, and their state gets worse, and then they have another comorbidity and so forth.

I found that unacceptable, that for so many people (it’s probably 30% of people that have some form of functional condition and autoimmune), we don’t have solutions. Drugs don’t really work for them. Research has not gotten so far to have anything meaningful, with sustained results. Then I just learned that we do have these therapies that actually are highly effective, helpful, and have pretty immediate impact. For someone that’s been suffering for 10 years, they can do therapy for a month or two, and that will dramatically improve their well-being, their quality of life, and heal them as a whole. It’s not just about the physical symptoms; your mental well-being gets better [and] your comorbidities will probably improve as well.

¬†It’s unacceptable to me that we don’t better support this class of patients, and we completely leave them outside of the medical system. Because they also pay taxes, they also have medical insurance, and mostly these are women that are left outside. This definitely drives me, knowing how much women are underserved and forgotten in many ways by modern medicine. We’re part of building this new wave of serving underserved patient populations that can really have better access to effective therapies. We already know they work, so why not make them accessible?

41:11 Eugene Borukhovich    

Amazing, and certainly your passion exudes. Thank you very much for taking the time. Always a pleasure.

41:16 Elena Mustatea    

It was great. Thanks so much.

41:19 Eugene Borukhovich    

Thanks so much for tuning into Digital Therapeutics Edition of Digital Health Today, a production of Mission Based Media. Be sure to hit that subscribe button to this podcast on your favorite podcast player, so you’re then automatically notified when we post our upcoming episodes, where I speak with dozens of leaders and trailblazers who are forging the path for digital therapeutics. If you’d like to learn more about YourCoach Health, or Brian Dolan’s Exits & Outcomes, you can always find the links to this and more in the show notes for this episode. You can connect with me personally on Twitter @HealthEugene, or follow my journey of writing my first book, Hard Pill to Swallow, at [email protected].

I’m Eugene Borukhovich, and catch you next time.

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