Elena Mustatea is the CEO and founder of Bold Health, a digital GI company that delivers digital therapeutics for the treatment of various GI conditions such as IBS. Their first app Zemedy is available in 190 countries. Now, they are hiring GIs and expanding in the US.
In 2018, Forbes listed Elena in a 30 under 30 list.
While private practice GIs are occupied with private equity, the world of digital health has been expanding. In Q1 2021, digital health attracted $9 billion in investments.
In this first-of-its-kind interview, learn more about Bold Health and the world of digital therapeutics, CBT, integrative medicine and the advent of digital health in GI. Elena talks about their business and operational models. She delves into getting paid by insurances.
Digital GI is a practical reality today. This train too is leaving the station.
Invest in your future by listening to this interview (25+min).
◘ Romania to UK to US: Elena’s background and the story behind Bold Health
◘ “We knew there wasn’t much digital health helping GI patients while this being one of the largest condition categories both by spend and also by prevalence”
◘ The mind-gut connection and why it’s important
◘ What’s the reason that we don’t have enough solutions in this space?
◘ “I think the system so far hasn’t really provided integrative medicine. We are big fans of the emerging model, where we look at patients as a whole”
◘ “Zemedy (an app to manage IBS) is now available in over 190 countries”
◘ “Standard medicine doesn’t work well with IBS because it is a disorder of the gut-brain link and it’s a functional condition not an organic one”
◘ Clinical outcomes of Zemedy
◘ Working of Bold Health’s business model
◘ “We are set up as a provider that can hire a licensed clinical team”
◘ “We seek to cover all GI conditions that you might want to see a doctor for”
◘ “We focus on being one point of entry for all GI needs in a digitally enabled format”
◘ “We are creating the most efficient, effective, convenient and delightful care for the patients”
◘ What happens when the patient is advised to visit the doctor in-person?
◘ “We are the only end-to-end digital GI care platform”
◘ What is your vision for GI and healthcare as a whole?
The Transcribed Interview:
Praveen Suthrum: Elena Mustatea, welcome to The Scope Forward Show. Thank you so much for joining me today, you’re the CEO and founder of Bold Health, a digital GI Company. Really warm welcome.
Elena Mustatea: Thank you so much really delighted to be here and I thank the audience for being here with us today as well.
Praveen Suthrum: You know when I actually saw your profile it seemed like a Mission Impossible movie cutting across different countries. So, you grew up in Romania, then I saw Italy pop up and then Germany and then you founded Bold Health in the UK, and then you were in New York. Now you’re extending Bold Health to the US. Then, of course, you’re part of the Forbes 30 under 30 list. So, congratulations on that. Please tell us the back-story here and what led up to the founding of Bold Health?
Elena Mustatea: Sure. Thank you so much for taking the time to research my background. Indeed I spent time in many countries. I studied in like five different countries and I took that with me in building companies and I always see myself kind of building global companies that make an impact around the world. And I think it’s important to have that international view of things and understanding different systems, different social implications. So, yes I grew up in Romania and I actually remember just growing up with a bunch of digestive symptoms. Lots of abdominal pain, various others and I thought that was normal because most people in my family had IBS, had ulcers. My dad; we almost lost him to an intestinal obstruction was in the emergency room and we were really afraid for him.
And yeah I would see people with all sorts of digestive issues, maybe it was because we didn’t have such a great water system in Romania and so forth at the time. But it took a while for the medical system to have a simple blood test… to tell you have that and then you get antibiotics and it’s gone. So, I’ve seen the benefits of standard medicine in improving gut disease. And later as I was working, I worked in management consulting and investment banking, venture capital, I had a pretty intense, very demanding job, poor lifestyle, working across time zones, taking many flights, working late, you know, eating if I could… I developed IBS – Irritable Bowel Syndrome that really impacted my ability to work productively to enjoy life, to go out, socialize, eat and drink whatever I wanted, it even affected my intimacy. So, I saw this very significant impact on gut symptoms on overall you know quality of life and also on my mental health.
So, really Bold Health was born out of the desire to help other people like me and my family but in general, people suffering from underserved conditions or even mystery conditions that we might not diagnose early enough. We might not know how to treat or they require a more integrative approach. Maybe it’s food as medicine, there’s medication, maybe it’s a psychologist that helps you work through the behavioral aspects, which frankly you know standard medicine doesn’t do today. So, I got together with my co-founder who is a doctor, very passionate doctor about technological innovation in healthcare. He’s run a number of digital health startups. He comes from Nigeria, a very international background as well. We knew there wasn’t much digital health helping GI patients while this being one of the largest condition categories both by spend but also by prevalence. We know 70 percent of American adults will have a recurring GI symptom and about 30 percent will have a diagnosable illness, right? So, very vast condition, are poorly served we believe at the moment and we see that anecdotally from our patients and then very little digitized. So, of course, building a digital health startup in this space felt a no-brainer.
Praveen Suthrum: Elena you talk often about the mind-gut connection. You’ve written about it and that seems to form a foundation for Bold Health as well. Can you share a little bit more?
Elena Mustatea: Sure. So, in the recent years, we’ve been learning a lot more about the gut-brain link connection and dysfunctions of this gut-brain connection. And what it is… it’s a direct link between the central nervous system of our brain and the enteric nervous system of our gut. We don’t know exactly how they’re linked. Some say via the Vagus nerve, there might be other nerve endings that connect the two brains. People say our gut is actually our second brain and evolutionarily, it was our very first brain – around digestion, life-giving digestion, right? And what we know it’s a bi-directional link that the gut affects the brain and the other way around. So, that’s the main insight we leverage in our work… that because our digestive system is responsive to psychological and behavioral factors, we can treat it leveraging behavioral medicine what we call behavioral medicine, and techniques within that are Cognitive Behavioral Therapy and Hypnotherapy. These have the best evidence-based development over the past 20 to 30 years that CBT and Hypnotherapy can improve digestive systems dramatically and actually in conditions like IBS which is the poster child gut-brain dysfunction affecting 15 to 20 percent of people, CBT and hypnotherapy are by far the most effective at around 70 percent efficacy rates. That’s more than prescription drugs, more than diets, more than probiotics, and others.
So, anecdotally a story – one of our collaborators at the University of Pennsylvania, she was telling us that every week she has a patient flying in from Toronto to Philadelphia to get their one-hour CBT with this therapist. And so, it’s a very under-served patient population and through our work, actually, we make these therapies accessible digitally. We aim to deliver the most effective and convenient digital care for GI conditions providing both a virtual care team an integrated virtual care team composed of GI doctors, dietitians, clinical psychologists, and health coaches as well as highly effective digital therapeutics for the self-management of the condition.
Praveen Suthrum: What you said made me wonder, you know it’s such a powerful insight regarding the gut-brain connection. So, my question is how come we don’t see as many solutions? What must be the reason?
Elena Mustatea: Well, first of all, we weren’t around to commercialize these solutions. They were being studied and researched for a very long time and even when we speak to clinicians all around the world. Really they’re like okay I recognize that CBT and Hypnotherapy are highly effective, I’d love to give them to my patients but it’s not really part of the standard of care we don’t have that type of service, you know we barely offer people 10 minutes consultations and a quick prescription. So, simply I think the system hasn’t really provided so far integrative medicine. So, we’re big fans of the emerging model in GI care where we look at the patient as a whole with both mental health, physical health, and a lot of other factors that I mentioned affecting their GI health and overall well-being. So, first of all, you have to innovate by bringing integrative care to people that does recognize the gut-brain link does recognize the importance of lifestyle and good nutrition, and brings in these pillars into care. But we know right now the standard of care, you go to the doctor, you get a medical prescription, and then go home and hope for the best!
So, that’s the innovation integrative care and when you look really at the behavioral interventions, it’s a bit counter-intuitive, right? That you would treat the very physical illness you know people have their deep abdominal, pain diarrhea for days or constipation, huge bloating, they are insensitive to anything they eat and so that’s a bit counterintuitive that by giving them Cognitive Behavioral Therapy and teaching them how to reposition, how they relate to the condition that would significantly reduce symptoms. But what we always did so that it doesn’t sound too alternative is to base everything in science so we collaborate with people at the University of Pennsylvania needing IBS centers in the UK or with Stanford University where there’s existing evidence, where there’s proven protocols and some of the best experts in the field.
Praveen Suthrum: So your first solution was Zemedy which is an app and that was launched just in the UK or is it available outside of the UK too?
Elena Mustatea: So, Zemedy is available in over 190 countries. What we wanted to do with our first solution and Zemedy is a digital care program for IBS – Irritable Bowel Syndrome, what we wanted to do initially is to serve the area of most acute needs which we identified IBS to be that. We saw the largest number of people affected 15- 20 percent of the population. Complete lack of effective treatment. Standard medicine doesn’t work very much in IBS because it’s a disorder of the gut-brain link and it’s a functional condition and not an organic one. So, we wanted to create a program fully digital initially that people can access by a digital app to get therapies that we know work with CBT and Hypnotherapy. They can access it at their fingertips, they can play guided exercises, they can go through patient education, and so forth and really self-manage, and use this app to improve their symptoms at home. So, with that in mind, we launched the app around the world. We recently are more focused on the UK and in the United States for commercialization but we want to make our apps available widely so that underserved patients can easily access them. So, this rollout of Zemedy that’s across so many countries.
Praveen Suthrum: What are the outcomes that you’re seeing?
Elena Mustatea: Absolutely. So, we see incredible clinical outcomes from Zemedy. At the moment it’s a fully digital intervention for IBS based on CBT and Hypnotherapy as I mentioned and we already knew from the evidence that the effects we can see are improvement in GI symptoms, improvement in mental health scores like – anxiety, depression, and stress, quality of life and a few others like visceral anxiety, fear of food, generally improved health. So, we’ve actually just published a paper in JMIR (Journal of Medical Internet Research) our first randomized controlled trial with the University of Pennsylvania, where we had 120 patients in two arms – the intervention arm on Zemedy and the waitlist where we saw clinically significant improvement across all of the secondary and primary outcomes of disease. Over 66 percent of patients in the clinical trial saw clinically significant improvement in their GI symptoms. For example in their quality of life and not only that we looked at three months follow-up and we saw that those courses were maintained. So, the benefits of an intervention behavioral psycho-behavioral intervention are magnificent because not only do you get that immediate impact or after a few weeks on the program, but that will be maintained over months and even years.
Praveen Suthrum: So, a common question that comes up in the GI circles you know when it comes to Cognitive Behavioral Therapy or anything that’s outside of the mainstream insurance domain is who will pay for it? In other words, what is your business model?
Elena Mustatea: Sure. Before that, I’d say you know where we start fundamentally is that we believe in value-based care that delivers the best outcomes for the patient and puts the patient at the center of care. So that’s very important for us not only to get reimbursement for our solutions but also to make it free or covered for the patients while they can be sure that they’re getting the best treatment and the best care they can. So, our model is actually hybrid so we provide a virtual care team telehealth access to different clinicians and then the digital therapeutic for the chronic self-management of the illness so we can get paid for those altogether or separately. For example for the digital therapeutic in some instances ultimately our model is B2B we seek to have coverage and reimbursement by self-insured employers or by health plans and insurers.
We also offer at the moment, until there’s broad coverage around the nation, patients can also buy directly from us. But ultimately we are focused on securing reimbursement across all 50 states. And we function both as a medical provider, so we can charge on claims as well as a technology company. So, for example, we can sell the software – the digital therapeutic on its own. So, then the operational implications is that we’re set up as a provider that can hire a clinical team, licensed clinicians, like dietitians or therapists and GI doctors and nurses while we also have a tech team, we have an R&D team under the parent tech company. So that’s a very interesting challenge to have – to coordinate this type of team and really two organizations that comes under one but it’s necessary so that we’re able to deliver care digitally.
Praveen Suthrum: With this type of model would you be continuing to focus on IBS or would you expand to other GI conditions in the US?
Elena Mustatea: Absolutely. So, we are a diversified GI provider. So, we seek to cover all GI conditions that you might want to see a doctor for. And IBS was our first proof of concept. Digital therapeutics condition area, we built the evidence, we’re building a portfolio of digital therapeutics across other conditions like inflammatory bowel disease and Crohn’s Colitis. We have another product for children with functional abdominal pain. So, not only do we cover multiple conditions, we also cover the whole family, both the pediatric population and adults. And then really we seek to be end-to-end GI care. So, from diagnostics to consultation to ongoing care support to digital therapies but also you know medication, prescriptions, and adherence, and so forth. So, being kind of one point of entry for all GI needs wherever possible in a digital or digitally-enabled format.
Praveen Suthrum: You know when a patient wants to be seen by you or when I say you, I mean either Bold Health or Zemedy or one of the solutions, would they be seen by a digital interface? An algorithm? Or a physician? Or all of it?
Elena Mustatea: All of it! So, we’re creating the most efficient care as well so the most convenient and delightful for the patient, the most effective, right? We’re all trying to improve GI care here. And the most cost-effective GI solutions in care. So, the way to do that… you want to leverage technology and digital as much as possible. So, you mentioned triage, right? Or even having AI algorithms that get the patient data either from here. Or they fill out an assessment and then get triage to the right clinician or the right treatment for them. And then we want to leverage technology at every step of the way and data. And of course with digital therapeutics, we even delivered therapies digitally.
But yeah, to answer more specifically we do an assessment upfront where we get the patient data their symptoms, and so forth, and then we empower the clinician that will see them with that data. So, it’s very effective they already have everything upfront and they can spend time providing quality care to the patient. And what’s interesting is we offer a care navigator, that at the moment would be a GI nurse that understands both GI conditions very well and all the different components of integrative care. And all the different clinicians that we might offer within the team and might serve the patient and after doing this assessment, the care navigator, the GI nurse will decide – does this patient need to see the GI doctor? Or maybe they should be put on Zemedy, on the digital therapeutic alongside seeing a dietitian.
So not everybody gets the same it’s a personalized care journey-based on data on the patient and what makes most sense for them and it’s a very high touch concierge type of service and even though this sounds like this cannot be cost-effective, because you give access to a full integrative team and you build whole technology infrastructure, we know from evidence that actually integrative care will be the most cost-effective because you prevent a lot of costs down the line when the patient gets much better or even enters remission closer upfront or in the first year or immediately after diagnosis.
Praveen Suthrum: So, let’s say a patient is seen virtually and the doctor determines that this patient has to go through a physical exam needs to be seen in person, or has to go through a colonoscopy what happens at that time do you refer the case to somebody else or would you also employ GI doctors to see them in person?
Elena Mustatea: Absolutely, so that’s a brilliant question and it’s very important, right? We recognize that in GI care many patients do have to get their colonoscopies on a recurring basis for example people with Inflammatory Bowel Disease that need to be monitored and there will be instances to do these invasive tests or see a GI doctor face-to-face. So, what we’re developing is a network of premium partners for in-network referrals so that around the country and in various in-networks of each health plan. For example, we can identify those clinicians that are high-performing that have good reviews, that we know are compatible with this integrative model of care, and see things in a let’s say progressive way and can refer patients into them so we see ourselves augmenting in-person medicine and standard care and supporting patients for this chronic journey. Because ultimately care is what happens you know after you’ve seen the doctor. And often you know standard care pathways won’t include a dietitian or won’t include a GI psychologist that we can offer to really augment and make better what patients might get from their primary care doctor or their main GI doctor.
Praveen Suthrum: I take it you would move in the direction of FDA approval?
Elena Mustatea: That’s not correct. So, at the moment we don’t have plans to go through FDA approval. We are a Chronic Care Management platform for gastrointestinal conditions we provide digital care pathways and for the digital therapy that we digitize, we position it as a self-management program ultimately CBT therapists or Hypnotherapists are not FDA approved so almost in that vein our intervention doesn’t need to be FDA approved.
Praveen Suthrum: Okay, that’s helpful. So, I’ve learned that Oshi Health is also positioning itself as a digital GI platform or digital telemedicine platform. How does Bold Health differ from what they’re doing? Or is it similar and more broadly who do you see as competition for what you do?
Elena Mustatea: Absolutely, so to clarify we’re the only end-to-end GI care digital platform. I would say and the two components are the virtual care integrative team – let’s say telemedicine for GI and then the portfolio of digital therapies for self-management for self-care that we give our patients access to. So, in that sense players like Oshi Health and GI-on-demand as well I think, are building a similar platform to Oshi that is virtual care, telemedicine/telehealth giving access to the integrative care team, which is fantastic! We believe in that and we’re very happy that multiple digital providers are emerging.
And then on digital therapeutics you know we mentioned Mahana, they do that. And now have the IBS product, they might go into other condition areas. The other competitor I would like to mention is Vivante Health. So, they’re also in the B2B space they’re selling into employers and insurers with a bit of a hybrid model where they have a care team with dietitian and health coach and then they offer an app and there’s information psycho-education and so forth. So, they’re a bit of a hybrid between the two but I’d say we’re the only ones set up both as a provider and offering the digital therapeutics.
Praveen Suthrum: Okay excellent, Elena let me ask you what is your vision for GI as a space and maybe healthcare as a whole?
Elena Mustatea: Absolutely. So, we believe in the world where people live free of the burden of chronic conditions more generally and when you do have chronic conditions you can get the right care immediately excessively and you can feel much better so that you can have a full life and limitless life as we call it at Bold Health. So, that’s a division of the world. In terms of GI care, we believe things can be made a lot better where patients can get a diagnosis faster. We know today they have to often wait over four years to get an IBS or IBD diagnosis. We find that unacceptable. Also in the world today, people don’t get access to effective therapies like CBT or Hypnotherapy even when they’re the most effective therapies. So, we believe in that world where you get access to the right treatment as soon as you get diagnosed, as soon as you have that need, and healthcare becomes not only very convenient but delightful, right? Where you know you’re being taken care of, you have a care team that you can have a relationship with, you feel supported.
And that’s something what we’ve seen with our app for example, in the feedback, some people tell us “I feel like this is my best friend, it understands what I go through, it knows my condition in and out and it can give me advice, it just tells the story that I’m living.” So, it’s really interesting how patients are coming at the center of care. We see the consumerization of healthcare where we expect you know really good service, really high-quality products which would be the care and the therapies and treatments we get and ultimately much better outcomes. So, I believe in GI we can produce better outcomes, faster with reduced costs. Ultimately, I’d say the world I see for GI is really integrative care in GI where we look at the patient as a whole, we understand the gut-brain link, we leverage it to treat people better and provide dietary support, psychological, support GI medication for the most optimal outcome. And we hope we’re part of creating that world I would say, all those different aspects of that vision where our platform builds towards that.
Praveen Suthrum: Wonderful Elena, thank you so much for sharing your views and sharing this vision. Were there any final comments that you’d like to share?
Elena Mustatea: No, I would just want to really thank you for the invite. I’m super happy that I was able to share our work at Bold Health and our vision for better GI care and thank everyone for your attention.
_
By Praveen Suthrum, President & Co-Founder, NextServices.
COVID-19: The Way Forward for Gastroenterology Practices