Category: Videos

22 Sep 2022

Dr. Kosinski: “GI is more vulnerable today than it was before” (SF interview)

Dr. Kosinski:
“GI is more vulnerable today than it was before” (SF interview)
Dr. Larry Kosinski needs no introduction. As a leader, he’s known for innovating, for breaking away from the norm and be a guiding light for the industry.  After a successful private practice career, he helped his group transition to a PE platform to work on SonarMD, a venture-funded company he founded. Now, he’s onto a surprising new startup, a stool-smelling e-nose called Voconomics (patent filed).
In this freewheeling interview, we chat about everything that GI doctors must pay attention to. The risks of running non-diversified “colonoscopy factories” (as he calls them). The shift to digital that would catch most of the industry by surprise. How doctors can find the time from their busy lives to innovate by mastering the basics. And finally his take on private equity.
This is such an important interview. It could quite easily alter the trajectory of many GI careers. It’s time to wake up to the vulnerability that private practice GI is in. Dr. Kosinski’s message is quite clear. Listen closely.
◘  Update on SonarMD
◘  Different initiatives Dr. Kosinski is involved with
◘  Is the average gastroenterologist aware of the impact of digital disruption in gastroenterology?
◘  Are GI practices still “colonoscopy factories?”
◘  A threat to GI
◘  “Right now, I don’t see the GI practices engaging with the digital health world”
◘  Are GI practices more vulnerable or less vulnerable to changes in the last couple of years?
◘  “The market will find the lowest cost way of providing services”
◘  Would disruption in GI appear to be all of a sudden?
◘  Thoughts on vulnerabilities within digital health trends (RNA test for cancer screening, AI, etc)
◘  “Patients will tell you that their IBD flare was associated with the change in the smell of their stool”
◘  Dr. Kosinski talks about his new e-nose startup: Vocnomics
◘  Dr. Kosinski’s advice to younger GI doctors on how to innovate
◘  “Master what you are trained to do, keep a focus, make sure you don’t overextend yourself and open up thinking time for yourself”
◘  “You have to understand your limitations, and not suffer from FOMO”
◘  “Master your revenue stream, so you can build new ones”
◘  “You can’t have a full time practice and be a full time CEO. One of the two is going to suffer”
◘  Thoughts on how private equity has played out in GI
◘  On second bites in GI
◘  “If these (private equity funded platforms) entities are going to succeed, their clinical infrastructure has to be as vertically constructed as their billing infrastructure is”
◘  Will private equity investments in GI continue?
◘  Venture Capital (VC) entering GI
◘  Dr. Kosinski’s advice to practices making a decision on PE
◘  “Don’t take a short-term payment and give up a long-term future”
◘  How to break away from a mindset that’s limited to the existing norm?

_
COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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09 Sep 2022

Erik Duhaime, CEO of Centaur Labs: Networks of people & computers will work together (SF Show)

Erik Duhaime, CEO of Centaur Labs:
Networks of people & computers will work together (SF Show)
Data is indeed the new oil.
Consider the strangeness of the scenario. GI doctors are supplying the fuel everyday that’s going to set the old norm on fire but don’t realize it. Because they are too busy generating the data!
The wrong approach to this scenario is to fear this shift to digital and block it. You really can’t. It’s multiplying exponentially. The right approach is to figure out how to play the game or prepare for this changing scenario. Educate yourself on the future of GI and go there before the industry gets there.
Erik’s company Centaur Labs helps AI medical companies cleanup and annotate the data that GI and other specialties generate. They do so by taking a crowdsourced approach. Thousands of medical students from around the world label polyps and other medical information via a gamified app. Centaur gives that labeled data back to Medical AI companies. Those companies in turn feed that data to the AI so that the AI learns the right approach to care.
I  kept asking Erik how much time we have before AI becomes mainstream in GI. He initially said, we are early in the cycle. It’s still far out. I persisted. Finally, he said we are possibly 5 years away.
As Erik refers to a quote on AI, it’s not about the AI replacing doctors. But the future belongs to doctors who will understand the AI and replace those who don’t.
Don’t miss this one. Your future self will thank you for it.
◘  The journey of Centaur Labs
◘  “If you want an algorithm spots polyps, you need data to train the AI” (helping medical AI companies develop new technologies)
◘  “We have a large network of medical students, doctors, and other professionals who are playing a gamified competitive app”
◘  The legal aspects involved in annotating medical data
◘  How does the data labeling platform work
◘  “MD vs AI”
◘  What are Centaur’s clients doing with the annotated data?
◘  “The fact that we are getting multiple opinions on a case means we know which problems people find confusing”
◘  “Doctors who understand AI will replace those who don’t”
◘  “Most doctors will be helped by AI for certain tasks very soon”
◘  “I think a lot of GI docs are going to be using AI for colonoscopy”
◘  How can GIs, private practices monetize the data they are generating every day?
◘  What is the future of medicine from Erik’s view?

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COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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11 Aug 2022

Greg O’Grady, CEO of Alimetry: “As clinicians, some of our skills may become relatively obsolete” (SF interview)

Greg O’Grady, CEO of Alimetry:
“As clinicians, some of our skills may become relatively obsolete” (SF interview)
As I write this note, I’m beginning to wonder what GI care means anymore. Just a few years ago, we were so sure of the role of the gastroenterologist in clinical care. Today, a flurry of digital innovations are urging the clinician to rethink her/his role. Surgeon and scientist and CEO of Alimetry, Professor Greg O’Grady reaffirmed how exponential technologies could make current clinical skills relatively obsolete.
Gastric Alimetry is a FDA approved device (below) that non-invasively senses motility of the stomach. Sensors capture activity of the stomach, relay it to an app, advanced algorithms spot patterns and generate a report for the clinician. It’s fascinating technology that’s been in the works at the University of Auckland, New Zealand for a decade.
Interestingly, in my book Scope Forward, I briefly talked about researchers working on a wearable device to track electrical activity of the digestive system and how algorithms would flag abnormalities (Page 51). Today it’s a commercial reality. The future is indeed coming at us faster than we think!
Don’t miss this one.
◘  The journey of Alimetry
◘  “Just like the heart, the stomach has its pacemaker”
◘  Why does the gut use electrical signals?
◘   What kind of GI diseases are detected?
◘  How does the wearable device by Alimetry work?
◘  How are the electrical signals detected from the stomach categorized?
◘  “We actually had 10 years of research going on”
◘  “We are a University spin-out company”
◘  The business model
◘  How can you buy this device?
◘  What kind of analysis is Alimetry doing from the data collected?
◘  What is the future of gastroenterology from Greg’s view?
“As clinicians, some of our skills may become relatively obsolete”

The Transcribed Interview:
Praveen Suthrum: Greg O’Grady. Welcome to The Scope Forward Show. I’m really excited to have you today.
Greg O’Grady: Thank you very much. It’s a pleasure to be here on your podcast.
Praveen Suthrum: So, Greg, let me outline your background. So, you’re the CEO and co-founder of Alimetry and you’re a professor in general and gastrointestinal surgery at the University of Auckland in New Zealand. So, thank you so much for joining. I’m curious to know a little bit more about your background and what led to the founding of your company.
Greg O’Grady: It’s a long story. So Alimetry for your listeners. We build wearable medical devices to diagnose gut disorders. And the sort of problems we’re really interested in are these disorders of function, sort of like the software of the gut, how it behaves and works and moves. So my clinical background is in surgery and I’ve been really interested in these difficult patients who often suffer a great deal with gastrointestinal symptoms and very hard to pin down a diagnosis on them at the moment. There’s a real lack of good tests out there. So I became very interested in these problems in the gut for my practice. And then I’ve done a lot of research on the gut and especially in the electrical function of the gut. And my interest in technology really led to the genesis of this company and ultimately Alimetry as it is today.
Praveen Suthrum: So, this research, can you talk a little bit more about this? What kind of research and why electrical signals of the gut? Has this been known for a long time or is this something relatively new that we know as an industry or a scientific community?
Greg O’Grady: It really has been known for a long time, but it’s not well known. So, you know, it’s been actually almost exactly 100 years since the electrical activity of the gut was discovered. And in that time, the guy who discovered it, Alvarez, 100 years ago, he actually made what he called his little prophecy that one day gastroenterologists would come to use electrical tools, just like cardiologists would to diagnose gut function. And really, it never happened, despite a lot of effort, wasn’t for a lack of effort over a lot of years that people really tried. But it’s difficult to measure these electrical currents just like the heart. The stomach has a pacemaker and it’s got an electrical system that drives the contractions of the muscles. But those signals, they’re 100 times weaker than you’d get in the heart. So it’s quite difficult to measure them from the body surface like you would for the heart. So a lot of my researchers and my team’s research and colleagues has been about tackling that very technical problem of how to measure these weak signals and bring them up to the body surface in a reliable way that we can measure them accurately and provide a useful clinical tool.
Praveen Suthrum: Let’s get to the basics a little bit. What is the stomach using the electrical signals for? We know what the heart does with it, but what does the stomach or the gut or the digestive system use It?
Greg O’Grady: For sure, it’s relatively similar. So, the electrical waste drive the contractions so that the muscle cells need that electrical signal to stimulate them to contract. And it should be nice and regular with the rhythmic digestive waves that happens in your stomach every 20 seconds or so after you eat. But just like in the heart, you can get arrhythmias where it becomes really irregular or fibrillation type activities, we call it in the heart, you can get similar dysrhythmias occurring in the stomach that become very disorganized. And it’s those types of signals that we’re aiming to measure and similar as well. You can get these ectopic pacemakers where the waves of the stomach start traveling in the wrong direction. And it’s these signals that we pick up and they correlate with diseases and with symptoms.
Praveen Suthrum: What kind of diseases?
Greg O’Grady: Really common ones. So about one in ten people would carry around with them some gut symptoms after they eat and maybe half the time that might be coming from the stomach. Things like chronic indigestion, functional dyspepsia. We call it gastroenterology or gastroparesis where the stomach doesn’t pump, working deep properly and nausea and vomiting. These are kind of the main things that we’re interested in.
Praveen Suthrum: How big is this problem? Globally or in the US.
Greg O’Grady: Yes, really common. Yeah, about one in ten. Globally, wherever you go, it’s a little bit higher than that in some places. And for some reason we don’t fully understand, it’s been increasing at about three and a half percent per year over the last 20 years. These distress after eating just becoming more and more common. And it’s a burden, a huge amount of suffering and health costs out there that goes into these problems.
Praveen Suthrum: What happens today when patients suffer from digestive disorders such as gastroparesis? How is it diagnosed or how does one know? Is it just a patient complaint?
Greg O’Grady: I would probably say it’s one of the most challenging areas in all of internal medicine because we lack a really good description of this disease, we lack a way to diagnose it. And patients turn up and often it’s not uncommon for them to undergo months or even years of a kind of diagnostic odyssey where they kind of bouncing around and they often undergo multiple tests that are always negative or inconclusive. It can be a really long diagnostic journey, not uncommon, at least in my part of the world, for it to be five years or so before they kind of reach some sort of finish line on their diagnosis. And in that time, there’s a lot of suffering that they go through, actually. And also the clinicians find it a real struggle to manage these disorders. So, it’s not quite as bad for indigestion type symptoms. But again, there’s a lot of negative testing that goes on and the battles for the clinicians.
Praveen Suthrum: Let’s talk about Alimetry. So, what does the device and the product or your solution, what do you do?
Greg O’Grady: We measure the electrical activity of the gut from the body surface, so it’s completely noninvasive, which is really nice. A lot of gut tests, they involve tubes or radiation and can be a bit unpleasant, but it’s really nice to have a non-invasive test. So, the patient comes in faster, and they sit in the chair. During the test, we prep the skin, and we place on their skin a wearable device. And that wearable device is where the real innovation is, a high-resolution device, meaning it has a lot of sensors on it. It’s got 66 electrodes and it’s so many because these signals are so weak and they’re so difficult to detect accurately and reliably, that we really pull everything we can out from the gut with this huge number of sensors that we put on. It’s completely wearable and it’s completely wireless and it’s a sticky patch that goes on over their abdomen and then they eat a meal, and they load their symptoms into an app we’ve developed so that we can correlate the changes that are going on in the gut with their symptoms during the test. And we get all that data, it goes up to a cloud and we send back a report to the clinicians so that they can interpret that with the patient and guide care.
Praveen Suthrum: Let’s talk about the electrical signals a little bit more. So, I saw what the device looks like and it’s quite fascinating. You said it’s capturing all these weak electrical signals and then I’m assuming you’re amplifying it, but could you categorize the type of these signals?
Greg O’Grady: We put all these signals together and we form them into visual tools that the clinician can use. So not like an ECG where the clinician would look at the individual waveforms. We kind of process them into the next level of doing these maps and visualizations and those show you a few things like whether the rhythm is regular, which should happen in the stomach, or whether it’s very scattered and irregular and really breaking down and breaking apart. And that indicates a neuromuscular problem with the stomach, that these nerves and cells that should be driving the contractions are failing. So that’s something that we can pick out with this test, for example, or we can pick out when these rhythms or waves become spatially irregular so they start doing the wrong thing or traveling in the wrong direction, which can lead to a different set of symptoms like bloating and pain after eating. And these sensors are housed in the device that is attached or spread throughout the white patch, the adhesive patch that you’re applying over the abdomen. Yeah, so it’s quite a cool technology. It’s a printed stretchable circuit. So we print these circuits like you might screen printed T shirt, for example, and we screen print these electrodes all over that patch so that we’ve got a very high density. And then on top of that, we put hydrogel pads so that you can just like an ECG dot, so you can really extract that weak signal. And an adhesive. So, you peel it off and you stick it on and on that all these individual electrodes that come together to form the patch.
Praveen Suthrum: Fascinating. Let’s talk about the business, Greg. So, you got started in 2019?
Greg O’Grady: Yeah, we started in 2019. Although going back, we actually had maybe ten years of pretty serious research going on in order to kind of learn how to do this. And it really wasn’t until 2019 that mature enough for us to think, oh, this is actually really exciting, and we’re kind of compelled to bring this out to the world and the product and the company as a vehicle to do that. So, yeah, it took a long time. Maybe 100 scientific articles were out there before we found the tricks to get it right. It was really hard.
Praveen Suthrum: Interesting.  Can you share a little bit about the funding situation? Did you raise money? How did you go about it? Or why did investors fund it? I’m curious about that, too.
Greg O’Grady: We’re a university spin out company, and the University of Auckland, like a lot of universities, have a really nice tech transfer process. And so we spun out of the university not only the IP and the technology, the patents and the algorithms, but we also spun out a team of really capable engineers with us as well. And so, we kind of carried that lab out at the university and into a commercial vehicle, which was a really exciting time. And university also kind of do a matchmaking process to introduce you to investors who are interested in these deep technology projects with really rich IP coming out of universities. And so, we met a great investor called IP Group who came out of Australia, actually, from a UK office in our most recent round. Another great investor called Movac led that round, and we’ve got a university, few others, that came together to form a syndicate to really back a great New Zealand technology that had come out of that academic environment into the real world so to speak.
Praveen Suthrum: Why not stay with your part of the world? Why approach the FDA in the US? And why are we looking at the US market?
Greg O’Grady: Yes, New Zealand is a beautiful place to live and it’s a really nice country, but it’s a super small country, as you may know. So, the total population in New Zealand could fit inside a lot of cities in the US or even in the UK. It’s about getting this technology to the world. And for us, the US is a super attractive market. There’s a lot of problem with these diseases everywhere, but the US is certainly not alone in that. And we’ve got a great relationship with expert gastroenterologists and research centers that we’ve had for a long time there. So, we’re very comfortable in the US and we love going there. So that’s a great market and a lot of fun actually.
Praveen Suthrum: What is the business model for Alimetry in the US?
Greg O’Grady: Yes, I mean it’s a pretty traditional business model for a diagnostic like you would a PillCam or other GI function tests that are done. So, there’s a kit that you buy and purchase and set up at the hospital and that’s got the reader device and so on. And then there’s the consumable, which is the patch. Once it’s used it’s sticky and unfortunately it can’t be reused. So that’s a consumable product that then the company sells for each use.
Praveen Suthrum: And who would pay for it?
Greg O’Grady: Yeah. So again. It’s very traditional out there in the market for patients coming through. At the moment, these tests, obviously one of the challenges for a medical device start-up other than getting through the regulatory is getting through that reimbursement journey is a major challenge for companies. We’re lucky in some respects and that there was an attempt to do this for quite a while out there a predicate technology and so there is a reimbursement code for example in the US. And there’s device that used to exist wasn’t particularly successful and so it’s about now for our company getting out there, showing people really what it can do and how useful it is and that will lead to adoption and use as clinicians find it useful and patients have successful outcomes. And on the back of that we’ll look to put that reimbursement piece of the puzzle into place so that it’s easier for people to do the test and get paid for it.
Praveen Suthrum: So private GI practice could potentially build for it buy the device, built for it?
Greg O’Grady: Yes, absolutely.
Praveen Suthrum: Are you seeing this to be a platform of some sort? Your view on the direction of where you’re going with the business?
Greg O’Grady: Yeah, I do. We’re very focused on the stomach in particular because it’s such an interesting organ that generates so many problems and it’s relatively easier than other parts of the gut to measure. But we’re very interested in, for example, the colon is a very interesting organ that you can also measure from the body surface. It’s not as easy and it kind of turns on and off and it does a bigger range of things but that’s another possibility. And also, I think the whole field is right. You know, there hasn’t been a whole lot of innovation in this part of the gut in this part of the body. And we’re at the dawn of this age of really exciting sensors and wearable technologies and data and AI and it’s really ripe for a whole innovative suite of products to come along and companies to come along and make the most of this and make a big difference in the process.
Praveen Suthrum: Are you familiar with companies similar to yours, perhaps not in gastroenterology but other specialties that are trying to capture electrical signals and do something with it? Let’s forget cardiology for a moment. But other than that, and of course the brain.
Greg O’Grady: Well, the heart and the brain are the two organs that are most obviously electrical, but a lot of other smooth muscles are in the body and squeeze muscles and things, I guess. But the hardest while we look at the wearable patches, the companies that are doing it very successfully and a very mature technology, the brain is interesting. A lot of companies, even commercial companies, you see them pitching to consumers, measuring brainwaves in various interesting ways. Super cool companies some of them. So we love that space. It’s really exciting to see what people do with all types of wearables. We’re data geeks and we love that measured cells; those different senses you can wear in your body to tell what your body is doing. And it’s exciting for us to be part of that kind of community. We’re medical device company but we do see ourselves as part of that wearable data driven trend.
Praveen Suthrum: If that is so, then why did you focus on going the route of getting reimbursed, working with clinicians? Why not allow it to be a consumer device? First, because there’s such a compelling need in the medical space and as a clinician, I find that really compelling that we can fill a gap, a diagnostic hole that’s been a real major problem for a long time and provide some fresh answers and fresh approaches. And also, the consumer market is about the use case. It might be interesting to measure your gut, but will it improve your life? Possibly. There’s a big question mark there. There’s a lot of companies out there looking at diets and opportunities, people very interested in knowing in fact different diets having their gut for example. A lot of people react to different foods. But can we provide that solution ourselves?
Greg O’Grady: I’m not sure yet. It’s a really interesting question but we’re 100% focused on medical for now because that makes total sense. But consumer would be interesting, if not us for someone else to do in the future.
Praveen Suthrum: So, is your product currently commercial or when is it going to launch?
Greg O’Grady: It’s available, yeah. It’s available in New Zealand and the UK. And the US. And we’re in market here in New Zealand early, but we are and, in the US, and the UK, we’re about to have our first commercial sites going as well. And we’ve had a ton of interest, actually, which has been really nice. So we’re busy scaling up the manufacturing and getting our processes in line and yeah, a it’s very exciting time.
Praveen Suthrum: If a GI doctor is interested in buying your product, how would they go about doing so today?
Greg O’Grady: Yeah, we meet a lot of them at conferences and through our networks because people are the early adopters, super interested in these disorders and patients. Our website is available as well, where people can go and have a look at what we’re doing at alimetry.com and see the device and they’ll get a good view from that, whether it’s something they’re interested in or not, and reach out to us and we’d love to work with them.
Praveen Suthrum: So, if you start viewing yourself into the future, let’s forward one year from now, three years from now, five years from now. How do you see the progression for Alimetry?
Greg O’Grady: You know, these new technologies, they go through a number of stages and what we really want to do, being clinician led as a company and having seen these patients a lot myself, what we’re really driven to do is to change the standard of care and to offer something that is genuinely answering the needs of the clinical community. And I’m as much a customer of that as I am the provider, so I feel that pain really strongly and identify with it. So, what we’re hoping to do is to make meaningful change and that will naturally lead to adoption if we can become the standard of care and provide those answers that are lacking for at least some of these patients. And if we do that, then everything else will fall into place for us commercially. That’s the road we’re on. And so far, so good. We’ve got some really exciting data coming out very soon that is, I think, going to get a lot of attention.
Praveen Suthrum: Talking about the data that you’ve captured so far, what have you learned from all this data, from the analysis? I know you’re doing individual analysis and providing it to the physician, but are you doing any analysis from all the data that you’re accumulating and what have you learned from it?
Greg O’Grady: Yes, one reason it’s an exciting field is because there is so much to learn. It’s not like the heart, which is so well characterized, that it’s really hard to learn something new from conducting normal studies. So even studying normal, healthy people, for us, we can learn a lot. We’ve generated hundreds of patients, now, many hundreds, and we’ve managed to formulate these, what we call reference ranges, where we kind of really understand what the normal digestive pattern is after eating what the normal amplitude of these contractions are and so on, and to put kind of a real circle around that’s normal. So now when we study these diseases, we can kind of start to put now the diseases int these, what we call phenotypes or boxes that fall outside normal and quite specific patterns. And the beauty of having the app is that we can pull the symptoms that are simultaneously being collected and then make these deep correlations with big data sets to work out what symptoms are associated with what patterns and what patients. And that’s something that will only get better as the data flows and grows so that we can really learn how to make the best of this tool.
Praveen Suthrum: So, when you look at these big data sets and when you’re categorizing these phenotypes, what are they telling you? Are you seeing with certain conditions, a certain phenotype? Are you seeing somebody is obese or overweight? Are you seeing a different type of phenotype? Somebody’s got a healthy gut. Are you seeing a different type of phenotype? Curious what you’re learning at this stage.
Greg O’Grady: Yeah, I mean, I can tell you about the I did tell you about that neuromuscular one where things become very irregular, but you mentioned overweight. And that’s something we’ve discovered very recently from looking at a large number of cases is that in our data so far, we’ve just put this out on met archive actually as a preprint. But if you have people with a higher BMI, their digestive time seems to be accelerated in their stomach. So, their stomach seems to be processing and working at a faster rate over a shorter period of time after eating. And we think this is a whole bunch of healthy, normal people, but with the range of weight. And so, for example, from this example, we think that one of the drivers for them being more overweight, maybe that they feel hungrier quicker because their stomach is processed, moved on, emptied, and they don’t have that same satiety that you and I might get from eating. So they go back to snacking, for example. That’s one hypothesis that’s come out of seeing that data with the patients with the higher BMI really having accelerated gastric time.
Praveen Suthrum: Greg, I’m curious to know what your take is on the future of gastroenterology, or perhaps medicine as a whole from the lens that you’re seeing.
Greg O’Grady: It’s an exciting time. It’s a little bit of a cliche, but I’m a big believer that we’re about to undergo some major changes. And the great thing about technology is that it’s exponential the rate of change. And so, I think it’s going to take people a little bit by surprise when AI and these big data things kick in. People at the moment are kind of in a little bit of a skeptical mode. It’s been around and talked about for so long that the kind of flying under the radar, the amount of progress that’s just being made. And at the moment I think it’s about to have a breakout and we’re going to enter this kind of zone of surprise where people are going to discover that the exponential rate of change is going to be quite surprising, and Gastroenterology won’t be spared from that. We’re already seeing the advent of AI and endoscopy and it won’t be long until that data power of data really spills out into other areas of Gastroenterology, as well as a super exciting time. And I love being on the side of it. Where we are promoting and bringing that change is certainly where we want to head as a company as well.
Praveen Suthrum: So, what if somebody is not on the side that you’re playing and is on the other side in the endoscopy room day and night, and they’re in that world and you’re saying if you catch them by surprise, are they going to be totally disrupted? Like, what’s your take?
Greg O’Grady: I don’t think so. It’s easy if you’re a technology advocate, to imagine that clinicians are going to be easily disrupted. But being a clinician myself and knowing the amount of training and experience and the integrated thinking that goes on when you treat a patient, it’s not so easy as replacing a clinician. So that’s actually really difficult. But I think our jobs will change in some important ways and we may find ourselves not doing so many repetitive tasks or some of our skills may become relatively obscure. So, you know, there will always be a role for the skilled clinician, but I’m hoping it will be for the better and maybe we can lose some of the more difficult aspects of medicine around the amount of time we spent maybe doing inefficient things or ways to improve what we do, make it less risky, more reliable and ultimately deliver better care. And that’s the future I think will happen. There’s kind of a nice tension between the technology always pushing into medicine and medicine kind of pushing back and adapting to that. And I think that struggle will yield better patient outcomes over time. So, I’m an optimist.
Praveen Suthrum: Professor Greg O’Grady, it was fantastic to have this conversation with you. Any final comments before you take off?
Greg O’Grady: Thanks for having me on your show. It’s been fun to meet you and talk about these things. And for our listeners who are interested, reach out to our website and be in touch. And yeah, we’d love to work with more gastroenterologists with what we’re doing.
_
COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
button_download
30 Jul 2022

RNA stool test with 95% accuracy to increase colonoscopies (Interview)

RNA stool test with 95% accuracy to increase colonoscopies (Interview)
In November 2021, a month after Dr. Haytham Gareer joined Geneoscopy as CMO, the company raised $105 million in funding. The company is developing an RNA analysis platform to detect colorectal cancer (to be launched in 2023).
A clinical study showed that when compared against the gold-standard colonoscopy, the platform demonstrated better sensitivity data in detecting advanced adenomas and colorectal cancer than other non-invasive tests.
Dr. Gareer says Geneoscopy is going to increase the number of colonoscopies being performed. However, it’s obvious to me that digital biology is disrupting not just GI but many other specialties that are diagnosing cancer.
I couldn’t hold my curiosity and asked quite directly. Should gastroenterologists be worried about them? Should Cologuard be worried? Should Medtronic with its AI-based polyp detection system be worried? Because when there’s a test that’s going to detect adenomas with a fair degree of accuracy, why bother with diagnostic procedures? Dr. Gareer had a different and interesting view.
As readers of Scope Forward, you already know my take. With more data, digital biology innovations such as RNA and DNA tests combined with machine learning would get extremely sophisticated. It’ll even be able to predict things that we just can’t with traditional approaches. Dr. Haytham completely agreed.
Watch this interview in full. Without doubt it’ll help you comprehend the future of GI.
◘  The journey of Geneoscopy
◘  The science of RNA biomarkers
◘  The thinking behind stool RNA test for detection of colorectal cancer
◘  What is the difference between RNA and DNA?
◘  Is the RNA test better than the stool DNA test?
◘  Availability of the test
◘  What is the business model?
◘  “Who do you see as competition for Geneoscopy?”
◘  Should gastroenterologists be worried?
◘  “We really think our test is actually going to add a lot of value to colonoscopies”
◘  “Our test will actually increase the number of colonoscopies being performed”
◘  How does the stool RNA test compare against other non-invasive tests?
◘  Will the test replace AI-based adenoma/polyp detection system?
◘  The role of machine learning in the product
◘  On digital biology as an exponential technology and the power of data
◘  Wider focus, wider opportunities
◘  What are the investors thinking?
◘  “The potential of the RNA platform for disease detection is very appealing to the investor community”
◘  What is the future of gastroenterology?

The Transcribed Interview:
Praveen Suthrum:  Dr. Haytham Gareer, thank you so much for joining the Scope Forward show. I’ve been looking forward to having this conversation for a long time now. We’re going to be chatting about RNA to test and I can’t be more excited to learn more. Thanks, I appreciate it.
Dr. Haytham Gareer: I appreciate you taking the time and I look forward to having our dialogue and our conversation this morning. So excited to be here.
Praveen Suthrum: Excellent.  Let me start by outlining your bio for everyone. Dr. Haytham Gareer is currently the chief medical officer of Geneoscopy. He’s responsible for leading clinical research efforts, collaborations with key medical advisors and professional societies, and providing critical insights to support commercialization and technology development across the company’s pipeline of products. Prior to joining Geneoscopy, Dr. Gareer served as VP Global Head of Medical and Clinical Affairs for Olympus. Dr. Gareer is an endoscopist with international experience. He’s received his MD in surgical oncology from Cairo University National Cancer Institute in Egypt, A PhD in surgical sciences and hepatobiliary and pancreatic illnesses from University of Verona, Italy. He holds a Masters in Minimal Invasive Surgical Technology from Italy as well an MBA from Hult International Business School and a Master’s in Applied Healthcare economics and outcomes research from Jefferson University. That’s quite a bit of an educational background and an expansive career spread and that to a global one. Is there anything remaining that you would be studying item from this point? Are you going to be studying more?
Dr. Haytham Gareer: Well, I’m considering law school. It’s a little bit of a stretch. No, I think this all kind of came together nicely. It’s just the medical experience combined with the business and the applications of medical knowledge and the medical domain and both the medical device and diagnostics, the education helped move this forward and drive this forward. So, my ability to contribute to some of the work that’s happening in the industry was supported well by this education. So it all came together nicely.
Praveen Suthrum: So you joined Geneoscopy as it’s a Chief Medical officer in October 2021. And the next month the company raised $105 million from various investors to advance stool-based RNA tests. So tell us about it, tell us about the company and about the product pipeline. How did it get started and how did you end up joining them?
Dr. Haytham Gareer: Yeah, absolutely. So Geneoscopy was founded in 2017 by Barnell siblings, Dr. Erica Barnell and Andrew Barnell. They really were the ones that started the company and helped develop and build it to where it is today. Erica was a PhD student at the time, and she uncovered the potential of RNA and really the proprietary technology behind being able to isolate the human RNA from stool and isolate that from all the bacterial noise and bacterial RNA and be able to harness that power to interrogate the RNA and be able to identify several disease states. And the primary focus they decided at the time would be on colorectal cancer screening to be able to identify the RNA biomarkers in stool and really be able to detect Colorectal cancer at an early stage. And we can certainly talk a little bit in more detail, but the company started with funding from family and friends as they called it at the time and didn’t really have a lot of capacity. There was no facilities or anything like that. They were really at the time it was Erica, Andrew and Yemen who was the software engineer or the range behind developing the algorithm that feeds into or. This essay helps feed into the company’s growing since and there’s a lot of progress. And as you mentioned, after going through a series A and series B, they were able to raise about $150 Million with a lot more recognition from key investors, strategic investors and also most recently they were able to certify some labs. Clear certified it’s over 11,000 square foot lab in St. Louis, Missouri where the company is based, where both founders Erica and Andrew grew up. And this is the headquarters for now for the company.
Praveen Suthrum: That’s awesome. Let’s start with the science. Tell us about what exactly the product is about, what does it do? And you mentioned one of the first people to come aboard was a technical person. So, what exactly did he or she will tell us a little more about the platform.
Dr. Haytham Gareer: So, as I mentioned, I think the essay is focused around being able to harness and identify RNA biomarkers in stool. RNA plays an integral role in tumor adjusts, the development of cancer, it’s role in cellular processes including proliferation, differentiation and apoptosis which allows for the development of proteins that then would be identified as part of the cancer development process is really the power behind RNA and how it is able to detect cancer and precancerous allegiance at an early stage. While the analysis of RNA stool has been extremely challenging in the past due to the nature of RNA being extremely easily degraded and being masked by the high bacterial burden and stool, the ability to identify and isolate those biomarkers are any biomarkers is really what this technology is about. And so this essay, the first test that the company is developing and we’re currently close to bringing to market is focused around isolating or combining the eight stool derived human RNA biomarkers, combining them with certain patient demographics like the smoking status of a patient as well as the people immunochemical test results. And that combination based on an algorithm would then help with a high degree of sensitivity, detect colorectal cancer, advanced anomalous and also precancer said no.
Praveen Suthrum: Did the founders go after stool RNA test for colorectal cancer, or did it just come about whether researching for something else and did this come about?
Dr. Haytham Gareer: I think the potential, as I mentioned of RNA is very vast. The focus on colorectal cancer is just the beginning so there’s potential for additional applications and it was felt because of the potential. As you know, colorectal cancer is a disease that is preventable if diagnosed early and treated. So, the social impact of this test, the potential application of this test and the indicated target population that would be best served by a colorectal cancer screening essay seemed like the ideal first step to move forward with this. There are other applications certainly and we can also briefly touch on that if you’d like. But really the colorectal cancer essays seem like the ideal first test for this technology.
Praveen Suthrum: If you have to explain as you would to a ten-year-old, how would you define RNA and what is the difference between RNA and DNA?
Dr. Haytham Gareer: So the RNA is really again as I mentioned, it is really part of the regulatory or regulate the cellular processes. So it’s part of the pathway that is associated with the initiation progression of several cancers. While DNA is really an indicator of the presence of cancers the ability of RNA be detected in certain tissues like stool and primarily why stool is ideal here is because the colonic mucosa exfoliates colonocytes that would then be shed into the lumen and accumulated in stool and those human colonocytes this eukaryotic RNA president of cells. We are able to isolate and identify at what stage in the progression of cancer that patient is and so be able to differentiate whether this patient is at a precancer stage with much higher sensitivity and specificity to DNA. So currently our initial clinical study just to give an idea of what that means differentially or in a clinical setting. The known precursor for colorectal cancer in most cases is an adenoma, right? Or an advanced adenoma. With a higher degree of sensitivity, RNA is able to detect advanced adenomas in patients than DNA and our first study indicated that compared to DNA we have a sensitivity of about 62% versus 42% with current DNA stool test. So we’re able to detect more advanced, enormous and potentially detecting cancer or the precancerous lesions in an early stage so we’re able to impact the prevention of colorectal cancer more. This is really the power of RNA and the power of our essays to be able to detect more of these precancerous lesions than a DNA platform.
Praveen Suthrum: Are you saying that it is way better than stool DNA test and perhaps FIT test?
Dr. Haytham Gareer: At the end of the day, it’s really the clinical characteristics of the test and how it is able to detect and differentiate the different types of lesions. Right? And because of that the higher sensitivity of advanced rate of detecting those adenomas against both DNA and FIT is much higher. So there is a superiority element in that particular aspect of precancerous lesion detection.
Praveen Suthrum: Now, this clinical study that you’ve conducted and are conducting, CRC prevent, can you share what you’ve learned so far from it and what is the purpose of the study?
Dr. Haytham Gareer: The intent is to move this forward as part of our PMA submission to the FDA to get the product approved on the market. This is a 10,000-patient study that we’ve begun about a year ago and we’re close to completing now. It has a very relatively high rapid rate of enrollment. It also had a very high diversity inclusion of the target patient populations. The reason for that is it was a decentralized clinical study approach. I think we’re one of the very few initial companies to apply that. So as opposed to working in a traditional setting where we work with sites specifically to patients and follow up, we use the decentralized approach. We reached out to patients through social media to be able to recruit them and include them as part of the study. What that means is really reaching out to a very diverse and geographically spread patient population. So the study is very representative of the target, the intended target population of the United States, where we were able to include a very diverse racial and very racially diverse, socially economically diverse. We were able to include patients from several statuses, including low income. And what we learned from this is really being able to understand a little bit more about the demographics of who gets screened and how they get screened. We were also able to learn a little bit more about currently and how the process would work. And we can also talk about how we’re going to commercialize this, but this is more or less the same approach. The results were still unblinded to the results of this study. We won’t be able to speak until mid or late August, but we believe it will be as promising as our pilot study with the targets that I mentioned, the 9th and the 62% and 95% sensitivity for advanced abnormalism colorectal cancer, respectively.
Praveen Suthrum: So when is commercialization? When would the product launch and be available for patients to perhaps buy directly online or get a prescription from their doctors?
Dr. Haytham Gareer: The incentives for it to be commercially available in Q1 or Q2 of 2023.
Praveen Suthrum: What is the business model for the company? Are you going to be selling directly to consumers? What’s the plan?
Dr. Haytham Gareer: We’re currently really ironing out the full process, but it would be a very similar process to the non- invasive tests that are currently available on the market. It would be prescribed by the patient’s primary care physician or gastroenterologist. We would receive the order and ship out the kit to the patient’s home, where in the box would include the return label. So the patient would deposit the sample and then it would be shipped back to our certified laboratory where a test is conducted and the report is sent back out to the physician and obviously if the test is positive or there are normal findings on the test, the patient would be asked to schedule a follow up call on colonoscopy. We’re working to ensure that our test is we’re not just focused on the kit or the product itself, but also incorporating comprehensive solution that would include patient education, that would include patient navigation through the process to ensure that the two- step screening test is a non- invasive test and a potential colonoscopy is followed through as part of our process. So really the component of a comprehensive colorectal cancer solution. We’re also looking into potentially including a telemedicine approach. We’re still working on the details for that but that would potentially be another option.
Praveen Suthrum: Back to the business model. Who do you see as competition for Geneoscopy?
Dr. Haytham Gareer: I mean, simply the prevalence of the other non- invasive stool tests is something to consider. We think of ourselves as a second generation non- invasive stool test. It’s something that would add definitely an incremental value to the non- invasive screening strategies that are out there in the market. It’s another option that physicians and patients could be offered with our improved sensitivity for advanced enormous. We think again, as I mentioned, there is a differentiator against other non- invasive stool tests, definitely much better than the Fit test and definitely there’s an incremental improvement over the DNA stool test. There’s also potential for what’s happening with the entrance for the blood tests. We think that overall, our cost effectiveness and navigation, the coral cancer screening solution that we’re offering will position us really well against those different noninvasive screening alternatives for colorectal cancer.
Praveen Suthrum: Let’s talk about that. So you’re saying that even if liquid biopsy, as they call it, to become a reality in the future, you don’t see that as coming in the way with what you’re building here? What I want to ask is if a single blood test or a blood sample can detect 15 different types of cancers as some of these companies are working on. Now here is your test working with stool RNA focused on one type of cancer. Don’t you see that as some kind of a business threat?
Dr. Haytham Gareer: There is definitely something to consider there and something to think through. So apart from the cost implications, and I’m not going to go into that in great detail, but there are associated costs with a lot of this unnecessary testing and this unnecessary screening and what it means beyond just that initial non- invasive test. The focus on one cancer or what our test offers really is again, because of the nature of the test, because of its ability to come close to the tumor and the pretumoral tissue in stool where at a very early stage before the cancer spreads beyond the walls or the layers of the colon to reach the bloodstream, it is still localized and limited to the colon. And because of the nature of the stool and how it allows for accumulating the exfoliated colonic cells. As I mentioned, it’s able to detect or pick up on these very early localized lesions much better than blood. So if blood is the option for treating this disease or managing and preventing this very preventable disease, there’s a very high chance that you will be missing on these three invasive precancerous lesions, right? So picking up on those in precancerous advanced or known as in the colon as an example, is really what would make this test a whole lot better. You would follow patients differently. You would follow patients and manage them in a much better and more focused approach than would a liquid biopsy.
Praveen Suthrum: So should Cologuard, be worried about you?
Dr. Haytham Gareer: I mean, there’s always a concern when you market entrance, right, if someone else is coming in, and in a general sense, there’s an opportunity for someone to challenge what’s been around for a while. There should be some thought around a new entrant, right? And to some degree there should be some consideration now that the market is and it’s just not just us. Again, we just talk about the luxury. So it will be more competition, obviously, and there’ll be more players in the market. So definitely there needs to be rethinking.
Praveen Suthrum: I’m taking away that gastroenterologists should definitely be worried about you. The stool DNA test, the liquid biopsy test and so on, shouldn’t they?
Dr. Haytham Gareer: We really think that our test is actually going to add a lot of synergies to colonoscopy and we’ll add a lot of value to the focus is really that there are, one that there’s a good percentage of patients that are eligible for colorectal screening that aren’t getting screened. That’s number one. So the compliance rate is about 60%. Right? There’s a lot of patients who would benefit from screening that aren’t getting screened. So introducing another noninvasive option onto the market that would allow patients an additional option, opportunity to get a noninvasive stool or noninvasive screening test. And those patients, those 40% or so would not have gone for a colonoscopy anyway. It’s just we’re targeting those patients, bringing them into the pool of patients that are going to get treated, that’s number one. Number two, because of, as I mentioned, our tests ability to detect advanced adenomas with a higher sensitivity, we have looked into modeling studies in health cost effectiveness, health economic models. We see that our test would actually increase the number of colonoscopies being performed. We’re going to increase the number of colonoscopies with a positive finding. So bring the patients and that aren’t getting screened today into the pool, but also the patients that would require a colonoscopy because they have some sort of positive finding will be the ones that are going through for a colonoscopy. The third value is really because of that, where it becomes a more targeted approach to some degree, where because of the COVID 19 and the backlog and the issues with getting patients adequately in for colonoscopy and time. You have a population of patients very well behind and you can’t screen everyone to bring everyone back at the right time. A test like ours, that would allow for more, I wouldn’t say selective, but at least making sure that the patients that are being offered a colonoscopy are the ones that are in need of a colonoscopy because of an abnormal finding, again, it adds value to the GI’s practice. So we think actually we’re here for the GI, we’re here for the patient, we’re here for the provider, the primary care. It’s not a test that’s going to take away from anyone who actually will add value to all the healthcare stakeholders from what we see. Right. And this is how we’re trying to position. I understand from a broader general perspective, but I want to read something from your website under the study, which I found quite interesting. You say it’s in a clinical study when compared against the gold standard colonoscopy. Our RNA based platform demonstrated better sensitivity data in detecting advanced diagnosis and colorectal cancer than that generated by any other available noninvasive test in their respective clinical studies, which is what you’ve been saying.
Praveen Suthrum: I hang around a lot with gastroenterologists in private practice and all that they dream about is screening colonoscopies. At least the last 15 years that’s been the case. Productivity numbers, the quality metrics, everything is set on ADRs, adenoma detection rate and so on. Now here comes a test in 2023 that’s going to even do the ADRs. I mean, they don’t have to do this, right? They don’t have to do the screening. It’s about 25, 30, 40% of what typical private practice does, depending upon how interested they are in doing other stuff in GI. Again, just very openly and directly. But you’re an endoscopist, so I’m curious to know your views.
Dr. Haytham Gareer: Well, I think you’re absolutely right. I know the detection rates and there are certain quality metrics for colonoscopy that drive the outcomes of colonoscopy. We think our test, if there’s a positive noninvasive stool test, be it our test or any of the other tests out there, this is potentially going to impact the quality metrics of a colonoscopy, generally speaking. So this can improve a colonoscopy. If the physician is unblinded or is aware of the results of a positive stool test, there’s an opportunity to improve the colonoscopy procedure, potentially improving things like withdrawal times and potentially even at no detection rates, more meticulous examination, right. Test will allow for that. It’s offering to those patients that are not willing to undergo a colonoscopy. This other option, then, if they have normal finding, they’re going to come in for that colonoscopy, which is really what they need.
Praveen Suthrum: Right, so it’s avoiding the unnecessary colonoscopy, but it’s also ensuring that patients that aren’t getting screened or those that are actually benefiting from a colonoscopy, I get the point that it’s going to expand the number of people who would go through a test because it is noninvasive and now they have more options. I totally get that. Even as you’re narrating this, I’m thinking even someone like a Medtronic that has an AI product should be worried about tests like this. Because here’s the AI trying to compete with the GIs in trying to detect or classify polyps and identify polyps and the adenomas, right?
Dr. Haytham Gareer: Right.
Praveen Suthrum: So you don’t even have to do that if the test itself is identifying the adenomas with the fair degree of sensitivity, is my understanding correct?
Dr. Haytham Gareer: If the test is negative? Right. The patient will not require a colonoscopy. If the test is positive or abnormal, the patient will have to undergo a colonoscopy. The procedure itself would still benefit the colonoscopy procedure itself would still benefit from enhanced technologies like AI and the ability to detect and differentiate lesions. Right. Because at the end of the day, there’s going to be still some therapeutic element that polyp needs to be removed or that lesion needs to be respected. We’re not at a point where we can say one is taking away from the other. The way I see it is that it’s all adding value. You’re increasing the pool of patients that are getting screened. The patients that require screening are benefiting from a more focused approach and benefiting more from that colonoscopy. Adding enhanced imaging technologies and other technologies that would improve the colonoscopy procedure itself is still beneficial to the patient. So I think that all feeds into an enhanced continuum of care, better improvement for overall outcomes. Right? Again, we’re all focused on one thing, is detecting this disease early, treating and making sure that we’re managing it early to prevent it from developing into something that is going to be more burdensome.
Praveen Suthrum: Some endoscopists that I’ve spoken to when I asked this kind of a question, saying that wouldn’t your bread and butter be threatened, they very rightly compared the trend to ERCPs. Earlier, So, you don’t do any more diagnostic. It’s all therapeutic. And that’s what I heard you just say. So we don’t have to do diagnostic colonoscopy and that should be a good thing. If the market or the endoscopy market or gastroenterologists embrace that, then they scope forward, as I like to say. They move forward. If they don’t, then I can’t see how they will not be disrupted. It’s just not about you. Right. There are a flurry of companies in this space trying to take different approaches to solve this problem. Before I get to my next question, I’m curious. How do you use machine learning in the product, in the company? What role does it play? What do you do with this data? What does machine learning algorithms do with this data?
Dr. Haytham Gareer: Don’t know if I can speak to the exact details, but I mentioned the algorithm that we’re utilizing. It said the information on the eight RNA biomarkers, the demographic status of the patients of smoking history, as well as the results of the Fit test. And what that does, it provides based on a threshold for all these inputs, it generates a binary report. Right. It’s either abnormal or negative, as we currently have it. So this is how this approach works. I don’t know if your next question is about AI specifically, but this is my kind of perspective. Just thinking ahead, maybe scoping forward the thought that maybe there are synergies there between a test like this and AI learning algorithms that are being developed for colonoscopy. Right? Could this add value? That’s something that if they play together, if you merge those two approaches, the positive noninvasive test with the procedure itself, can the results be merged? Potentially, but I don’t know currently if that’s an option. Today, our test just uses these inputs and the algorithm provides a binary output for test results.
Praveen Suthrum: Yes. No. The reason I asked that question first was because my assumption would be that with more data, the test would get more sophisticated. Broadly, the space comes under digital biology, and for me, digital biology would come under exponential technologies. And if you look back at any of the exponential technologies, for example, I sat in a self-driving car back in 2012, and at that time, it was a research project. I was in the Bay Area, and like, it was a Google car, and the laptop was connected to the steering wheel with wires going all around and the LiDAR scanner on top of this huge and it was all bulky. But now it’s more than a reality. So my take has always been that you give digital biology a few years, and because of more data, because of the number of tests that, for example, Cologuard has screened about 3.5 million plus people, the last time I took a look at that, I’m sure you would go down that path, you would get all this data, and with this data, there would be more analysis. And with the machine learning algorithms, it’s going to be able to predict I mean, I don’t think that it’s going to be remotely any competition with the ability of a human being to predict screening I can understand because it’s a sophisticated skill and an art, but this is a prediction. You would be able to predict things that I don’t think we’d be able to do in the traditional approaches. What do you think?
Dr. Haytham Gareer: No, I completely agree. I think you’re absolutely right. The more we learn about this, the more we learn about the power of RNA. And as I mentioned, this is not just a test. We consider this a platform because the potential for utilizing this test is different for even higher risk cancers, for other disease stays, for other GI too there’s always going to be an opportunity to learn how there will be different iterations of this test to begin with. So the ability to develop the test even further and enhance the sensitivity and specificity from where it is today, but also the applications with other disease states and how it interacts with different diseases and it can lead to cancer. So you’re absolutely right. I think the potential for it to grow and expand and evolve beyond where we are today, leveraging machine learning algorithms is definitely a possibility.
Praveen Suthrum: In your knowledge, how many such companies are there like broadly playing in the space? DNA testing, RNA testing, not just with GI, but medicine in general. Are we talking a hundred? Are we talking 1000? What would be your guess?
Dr. Haytham Gareer: In the hundreds of the space is evolving rapidly. The ability to focus on molecular biomarkers and tests in general is something that is advancing as the technology for sequencing and everything that feeds into this industry is improving and enhancing. There’s definitely an improved threshold for detecting at a much earlier stage, more advanced stage. I think the focus is also very broad across different diseases. So it’s not necessarily all focused on just GI or colorectal cancer specifically. I think there’s a place for lung cancer, bladder cancer, other disease states as well that are not necessarily immediate correlate to oncology as well as being able to follow up patients and predict. So the focus is not always on screening. There are companies out there, technologies out there that are focused on monitoring for residual disease, looking at prognostic indicators, monitoring therapies so there’s a lot that’s being done in this space and I think it’s expanding rapidly and it’s ultimately good for everyone. It’s good for patients, it’s good for therapeutic development, it’s good for the healthcare system in general that these technologies are being picked up and coming into play. But the focus is diverse, which is also good, right So we’re focused on GI health primarily and we think that our technology, the RNA technology will play a huge part in that space with DNA and proteins and the other biomarkers that are being utilized. There are opportunities for other things, but he’s out in the hundreds, which is good.
Praveen Suthrum: What are investors thinking? They’ve given you they’ve invested a significant sum of money. What are they thinking? What do they know?
Dr. Haytham Gareer: While colorectal cancer is really what we’re selling on our focus, there’s an opportunity for pipeline development as well. And this is really what we try to highlight, that there’s more than just colorectal cancer or potential for that with our RNA platform. But the promise of colorectal cancer itself is great, right? The ability to benefit this vast patient population that needs to be adequately screened, the gaps in compliance and being able to detect with a better sensitivity the precancerous lesions. I think this is all a great selling point to investors. The fact that we’re addressing this disease state is good and it’s very appealing. But also the potential of the RNA platform we believe is also going to be very appealing in its potential. For high risk patients, for other diseases I mentioned, like inflammatory bowel disease and others. And also the applications were being utilized as a companion diagnostic. So the utilization of this test to help even develop therapeutic drugs and other things, there’s a whole lot that we can offer with this platform that is potentially very appealing to the investor community.
Praveen Suthrum: If you were to advise GI fellow, what would you tell him or her? They are crossroads, right? What to do with their carrier over the next 40 years from that standpoint?
Dr. Haytham Gareer: Yes.
Praveen Suthrum: Given what you know about where things are going, about where things are and so on.
Dr. Haytham Gareer: I’ll try to be very broad because it’s very general, but I think medicine is now very interdependent on a lot of things the domain knowledge of medicine, understanding about diseases, pathologies and managing patients, and being able to be that bedside position where you’re caring for the patient directly and following up. But there is an opportunity now, I think, more so than ever, and I’ve been part of this kind of my career, is the technology component, right? And technology can have multiple avenues. It’s not necessarily just focusing on, for instance, the scope or imaging technologies, but things like what we’re discussing here now, the technologies that leverage even molecular genomics and being able to help predict where patients can be managed better. So just to be open minded about the practice of medicine, that it’s not just focused on what you can learn or it’s not just the medical and clinical knowledge, but there’s an opportunity to be more broadly focused on what’s next, what the technologies can bring and how they can benefit that. So nothing threatens the practice of medicine, but I think everything expands and improves outcomes ultimately. So to be focused on an open minded about what’s coming, what’s next, and be well informed on the advances and everything beyond just the practice of medicine, the technology around you, because everything’s coming together, right? We talk about AI, we talk about wearable technology, we talk about integrating patient information and data into cloud. So there’s a lot that needs to come together into play. And the more informed the physician, the more informed the GI, the better they’re able to stay up to speed and manage patients.
Praveen Suthrum: This naturally segues us into my final question, which is on the future of gastroenterology. So if you have to look ahead five years and then ten years, what do you see?
Dr. Haytham Gareer: I mean, we talked about it briefly, and again, this is my perspective. I think there’ll be more and more of the need of the advanced interventional therapy, the role of the Gist of this, talking about the endoscopy space, right? The colonoscopy endoscopy space. There’s definitely going to be more and more of a trend towards focusing on the therapeutic, the early stage management of diseases. The earlier you identify diseases, the more amenable are the early treatment and early cure better managing patients based on precision medicine or precision surgery approach. You focus more on what the disease is at what stage, and being able to manage that early on and control it. So I think we talked about it’s not going to be always the screen, right? We’re going to rely less and less on the ability to use invasive procedures in general. This has been like the trend over the past few decades, less invasive procedures for diagnosis and even less invasive procedures for therapeutics. Right? So I think to be able to stay on top of that and focus on technologies that would better serve the therapeutic component of the practice is going to be very important. That includes AI, that includes robotics, that include endoscopy suite ecosystem, integrating imaging, integrating information, integrating big data and all that into the endoscopy suite. Essentially, I see that heading in that direction. A more informed, precise, more precision focused management of patients and better care.
Praveen Suthrum: Dr. Haytham Gareer, thank you so much for spending your morning on the Scope Forward show. I learned a lot from this interview and it validated a lot of assumptions that I’ve been having. And thanks so much for sharing your perspective, being open about playing and going in the direction that I was going, but thoroughly enjoyed this conversation.
Dr. Haytham Gareer: Thank you so much. Thank you so much. I really enjoyed this too, and hope this is useful and look forward to staying in touch with you in the future. Thank you. I’m always interested in what you have to offer, so it was great to speak to you this morning.
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COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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26 Jul 2022

Sonia Grego (Co-Founder at Coprata): Oura Ring for sleep. WHOOP for activity. Now, Coprata Smart Toilet for stool

Sonia Grego (Co-Founder at Coprata):
Oura Ring for sleep. WHOOP for activity. Now, Coprata Smart Toilet for stool
It’s something that we take for granted — until we can’t. How patients communicate about stool is anything but objective. What’s missed in translation is the ability to diagnose and treat GI conditions in a timely manner.
Therefore, it was with much intrigue that I began my conversation with Sonia Grego, PhD. She’s a professor of electrical and computer engineering from Duke University, the founding director of the Duke’s Smart Toilet Initiative. Her team worked for eight long years to develop a smart toilet. They spun off the innovation as the startup Coprata that has won competitions at Harvard. The Coprata toilet captures lots of data post flush, runs AI algorithms on the data and provides the analysis to both patients and doctors.
I came away super impressed with this at-home biosensor for GI tracking.
One, the market is showing us repeatedly that many new innovations in GI are coming from outside of the specialty. As a gastroenterologist, you must consider that as a missed opportunity.
To stay relevant, it’s so important to stay up-to-speed with what happens beyond the endoscopy room.
Two, increasingly new devices are preparing the ground for digital-first GI care. The smart toilet can go in many different directions from here. With scale, it can create so much ongoing data that it has the potential to change the trajectory of how much GI conditions are managed.
◘  How did Sonia Grego, an engineer/PhD start a smart toilet company?
◘  “There is a lot of data in stool and it is very difficult to get it”
◘  How does the smart toilet work?
◘  Does the user replace their existing toilet with a smart toilet?
◘  Does it operate on electric or battery power?
◘  What sensors are used? Does it have a camera?
◘  How does the collected data get transmitted?
“We believe Coprata toilet will truly be an at-home biosensor for GI tracking”
◘  Can the smart toilet differentiate between multiple users?
◘  “We have developed an algorithm on 3,000 images”
◘  “Sensor-based analysis of stool will provide clinicians more accurate data”
◘  Coprata toilet will empower clinicians to reduce uncertainty in prescription and management”
◘  Which disease conditions can be detected with a smart toilet?
◘  What is the business model and revenue sources?
◘  What is the future of GI in Sonia’s view?

The Transcribed Interview:
Praveen Suthrum: Sonia Grego, welcome to The Scope Forward Show. I’m very excited about this interesting topic. We’re going to be talking about smart toilets. So, I first want to welcome you, Sonia. Thanks for joining us today.
Sonia Grego: Glad to be here.
Praveen Suthrum: So, Sonia, I want to get started by sharing a little bit about your background. Sonia Grego, PhD, is founder and CSO of Coprata and professor of Engineering at Duke University. She has led the development of a smart sampling toilet that automatically captures stool data post flush, and she’s passionate about bringing this product to GI patients to improve outcomes. Very interesting background, I must say. But I want to start by asking you, I’m sure growing up or while studying engineering, you didn’t dream of working on smart toilets. So how did this come about?
Sonia Grego: It’s been an interesting journey. So, my PhD is in physics, and I have over 20 years of experience working in applied technology and engineering, developing biomedical technologies. I worked on wearable sensors and biosensors in a variety of capacities. I started to be interested in toilets a few years ago, I would say eight years ago. Myself and colleagues here at Duke University, we have an entire center that has had large programs funded by the Gates Foundation to develop toilet technology. If you think about it, toilet is a fantastic appliance, very effective in doing its job of removing waste. It has not changed since it was first introduced in the home in the beginning of the century. It’s a white ceramic bowl with water and you flush it, and your waste goes away. And it is fantastic for that. As we were working on technologies for treatment of the waste, we posed the question, and particularly my interest in biomedical technologies to have an impact on health. We wonder, well, is there data in this waste that we are flushing away? Can we capture it before we flush it away? And the answer is a resounding yes. And that is what we set up to do, technology that analyzes school data. Also, I want to add in my experience with sanitation technologies for other environmental applications. We have deployed and tested many toilets with real users, and we become aware of how sensitive the topic of using the toilet. It’s a private, personal act and users, and particularly women are very sensitive about the use of a toilet. So, we had designed a product for the Coprata smart toilet. We went really great engineering effort to design a product that does not appear different to the user so that it doesn’t engender discomfort.
Praveen Suthrum: I just want to delve a little bit deeper. Was there a certain trigger? How did the exact idea come about or were you just simply thinking, hey, we got to measure stool data? There is a lot of data and stool, so let’s figure out a device or make a device that helps us do that. What was the process there?
Sonia Grego: Well, the process was, we know and speaking with physicians, collaborators and gastroenterologists here at Duke, we learned, yes, there is a lot of data in stool, and it is very difficult to get it. Gastroenterologist collaborators told us that they spend most of the visits with the patients just figuring out what was the regularity in the bowel movement that is associated with the concern that brings them to the visit in the first place. They say, well, 90% of the visit is just figuring out the consistency. What do they mean, the volume? Is it little? Is it a lot? What little? What’s a lot? People do not have a frame of reference because it’s a private fact and everybody only knows what they are doing. The physician told us, yes, I would love just to know how much they tell me. They go to the bathroom 20 times a day. Is that really true? There is something coming out really 20 times that seems impossible. And yet there is this mismatch between what patients report and what clinicians understand. So, there was data in that. And then additionally, they also said, well, and when you need a stool sample, you send them home with a stool kit and you get it back. Hardly. Maybe 40% of the time, people just don’t want to do that. So, the need was explained very clearly to us. And we said, well, of course, you could just engineer something that scoops down in the bowl and picks it up or takes a picture of it from the bowl and you’re done. But that’s where our engineering experience said no, I mean, you can do it, but if you can do it, you should not do it, because nobody will ever use it. Our experience is everything has to happen in a system that appear normal and usual to the user. Toilet users, they just want to see a white ball, no gizmos around it, water in it. That’s it. That’s the only thing they want to see. So, he said, well, in our laboratory we are completely set up to test toilets. We have them on laboratory benches. We are very familiar with the physics, the fluid dynamics, the engineering of the whole system. We said, okay, let’s figure out how we do this stool analysis after the stool has left the bowl outside the purview of the user. Well, that’s easier said than done. That was months of brainstorming and test and tried and truth. So, our current technology is the result of a large number of tests and failures. But now we have it and we think our approach is unique and it is possible.
Praveen Suthrum: Can you explain to me what exactly it does and how it does what it does?
Sonia Grego: The principle is all toilets are designed to take the waste and move it to the switch line as fast as possible. So, you flush, and the hydrodynamics is designed, fluid dynamic is designed in such a way and the stool moves very quickly down the drain. The point of our invention is we were able to immobilize it for a brief moment and in a reversible way. So, whatever happens in the pipe to the stool after it leaves the ball is it stops in a region of the plumbing. For a brief moment, all the sensors are placed, and we get the information that we need and then the stool proceeds being flushed away. So, we have a toilet that is designed to do sort of the opposite of what regular toilets do. Yet the appearance of it to the user and to the customer is of a very regular toilet. We could show you a picture from a toilet from Home Depot, you could not tell the difference. Which is the point. And we think that will really facilitate adoption because people, for example, this is designed for residential use to be installed where people go to the bathroom, which is at home, in case they have family members, they don’t want to be tracked or a guest coming in the home. We want the toilet to look like a regular toilet, but yet being able to capture all this data.
Praveen Suthrum: So, this is the entire toilet itself. If a user has to use it, they go to replace their existing toilets.
Sonia Grego: Yes, we understand that’s something that people do not often change their toilets. So, this is a great opportunity. The installation is provided as part of the product is a 90 minutes operation and the toilet that is removed, we have a reuse of it. We crash material for construction, so we have a sustainable approach to the reuse of the old. We called them unintelligent toilet. The user has to install a whole new toilet but will make the experience as seamless as possible and that is a one-time operation. After that they will have a toilet that operates like a regular toilet, but as an opt in solution. The member of the family that wants to be tracked, they will use the toilet as they regularly do, but then on their phone app will appear data trends that describe the values and the information that our senses and algorithms produce.
Praveen Suthrum: I want to talk about the sensors. What kind of sensors are there and I’m assuming you’re taking a picture also. I’m curious, how is that possible? Now, is the toilet plugged in to an electrical socket or is it battery operated?
Sonia Grego: The system requires power the same as conventional smart toilets that are on the market. There are products that have features such as heated seat, incorporated bidets that require power. So, this system does require power. So, it will be either a socket if that’s available, or power operated, or battery operated with a rechargeable battery like your power drill. And in the absence of power, it does not record data. That’s the only thing that can go wrong. It still works like a regular toilet unless a signal is given, and the data is collected. So, it just operates normally. Indeed, there is a camera, and let me specify again, the camera is in the plumbing. The background image of the camera is a piece of pipe. So, there is no concern whatsoever that the user or the bowl is ever involved in this imaging. So, we capture images of the stool, and we have extremely high-quality images. We also have other sensors that are commercial off the shelf sensors or sort of customized physical sensor devices. So, we are able to capture parameters of the store properties, which are what clinicians typically ask of patients. So, whether it’s a urination or a bowel movement, what’s the consistency? Both from images as well. We also have a specific diarrhea sensor that measures the turbidity of the wastewater to capture the component of a liquid stool and that allows altogether to have a complete. We have the full range of Bristol scale from one to seven unusual colors and presence of blood. And importantly, also sitting time and the duration between your first sitting on the toilet and when excretion occurs. Because that we believe is a surrogate of urgency or straining. Which are parameters that clinicians are interested in knowing about and currently are just qualitatively expressed.
Praveen Suthrum: How does this data, I’m assuming this data gets transmitted either via Bluetooth or the cloud and go somewhere. So, tell us that process.
Sonia Grego: So, imaging, and analog sensors, and these are operational, and our first pilot is ongoing in our own facilities. So, we are collecting the data as we speak. The data is collected and analyzed on our own servers, and it is coupled with algorithms so that all these signals become actually information parameters. So, people will get a score about their sitting time and their changes from a baseline.
Praveen Suthrum: So, Bluetooth. Or is it Wi-Fi enabled? How is it getting?
Sonia Grego: We can configure this. Made it at the moment is Wi-Fi enabled just for convenience.
Praveen Suthrum: Just like a smart TV. Now there’s a smart toilet like you configure to your home network. All this gets analyzed and relayed to an app.
Sonia Grego: Yes, we envision the data as summarized enough in form of a dashboard for the convenience of the user. So, one of the questions that we always receive is once the toilet is installed, these sensors will work indefinitely. So, it will capture pictures of every bowel movement. One user, one bowel movement per day. If we had 100 toilet installs, we would have 200,000 data points in a year. So we believe our Coprata Toilet will truly be an at home bio sensors for GI tracking that so far has not been developed and the data clearly needs to be summarized in dashboard, both for the users and for the clinicians that are interested in seeing it. So for the users we envisioned an app, and for clinicians, some form of easily transferable information.
Praveen Suthrum: I’m assuming that the toilet is designed for a single user. What if more than one person uses the toilet? Does it differentiate between one person’s stool and the other?
Sonia Grego: Yes. There are many ways in which the toilet can differentiate the user and we envision that customizing on the customers. Younger clientele are happy to just have the toilet recognizing the cell phone that is approaching the toilet. For older users, people have asked us can I just have my own button? So when I use my own flush button, I’ll flush that button. So there are many ways in which the toilet recognizes users, but I always specify that will be customized to the client and how many people want to be tracked. And people that don’t want to be tracked will not be. So It’s an opt in system.
Praveen Suthrum: While the development of the product is going on. How does one even test for something like this in a lab or at the university?
Sonia Grego: We certainly tested extensively on laboratory benches before we ever installed in a bathroom. And we have here at Duke University a unique facility that was designed to test toilet. So we collect specimen donations, stools from healthy volunteers and pour flush in the toilet. And that’s how the science is being done for development of the technology. So it’s a unique capability, but we happen to have it and we are very confident of the quality of the product we have developed. It comes from a sort of deep bench of knowledge and capabilities in this specific space.
Praveen Suthrum: Do you have a number in terms of how many data points that you’ve collected so far? What kind of data have you collected so far in terms of, I want to talk about quantity. I understand the quality of data. I just want to curious about the quantity of data that you have.
Sonia Grego: I don’t have it off the top of my head. We have developed an algorithm on 3000 images. Those were obtained by crowdsourcing. We have published a study on the ability to sample the stool ones from the toilet. And there we had hundreds of data points and for the toilet that we had installed. Now we have just a few months of data, you can calculate multiple up to five users per day, times seven times a few months.
Praveen Suthrum: What have you learned so far?
Sonia Grego: We have learned from a stool image. An algorithm is very good at recognizing consistency and as reliable as clinician. There are studies in the literature, since this is an area that is being investigated, other studies have reported that algorithms are better than people at recognizing the specimen. We are really comfortable with the assessment that sensor-based analysis of stool will provide clinicians more accurate data than what a patient could do, just turning around and looking. We have also learned that it is possible to sample the stool from the toilet region and it’s possible to conduct biochemical analysis on that sample. This capability is not in our product yet. It has been characterized separately and with funding from the NIH. So our platform has like near term ability to collect all the information on the bowel movement, but it will also be developed longer term towards stool sampling and having a fecal specimen that can be sent the Laboratory for Biochemical Analysis.
Praveen Suthrum: This is the earlier version of the product, but once you get to later versions of the product, what do you hope to achieve in terms of the science aspect of it? From the scientific aspect?
Sonia Grego: We think the Coprata toilet will be first tool that empowers people with their data so that they can take better care of themselves, to have longitudinal data about their bowel habits, so they understand when a lifestyle changes, makes any fact. They will empower clinicians to reduce uncertainty in prescription and management. In my conversations with Gastroenterologists, they always say, well, I’m trying this, I’m trying that. They tell me it’s not working out. I’m surprised that the patient gives me this feedback that I feel like it’s almost impossible. I feel like there is a great uncertainty. I hear clinicians talking in follow on conversations with their patients, looking for potential alarm signs that the diagnosis was not right. So, I feel like that especially in many chronic GI diseases like IBS or disorder brain interactions, there is so much uncertainty from the clinician and the patients. Our dream is to put this uncertainty to rest, or partially at least, with a steady stream of information that rules out the alarm bells. I was told, for example, that bowel movement, nocturnal bowel movement, are an alarm time. I’m like, wow, so something just like a timestamp when you have a bowel movement could tell your physician that, wait, there is something wrong, the condition is evolving, and we need to do a different treatment. That’s something that our tool would be able to do. And give peace of mind to caregivers for caregivers of children or vulnerable populations that cannot speak for themselves of what’s going on in the bathroom. So we want to give patients and clinicians certainty and value from the data much longer term. We envision that the stool sampling capability will be added to our platform and that will have to be an FDA clear device. So, the development timeline is a bit longer for that one, but that will empower, for example, celiac patients to check for inadvertent consumption of gluten in their stool, to conduct microbiome tests, to conduct stool tests for patients with IBD, or for patients for which fickle test is recommended multiple times a year and is not a pleasant act.
Praveen Suthrum: What kind of disease conditions are you currently planning for?
Sonia Grego: The toilet would benefit patients with all sorts of GI conditions that result in power regularity, which is practically all of them, but particularly the IPS functional constipation people type of an IBD patients would immediately benefit from the toilet. We also think that health-conscious people, even people that are not currently patients of GI but, any health-conscious person that has an Oura ring to track their sleep, that has a whoop to track their physical activity, would benefit from tracking their bowel movements so that they see what their diet and lifestyle does. I mean, regularity and gut health is health and happiness for the person. We also envision used in of course research studies and clinical trials. Like clinical trials, particularly for GI conditions, they rely on facial self-report for many of these improvements in bowel movement frequencies or straining or urgencies. And we believe our technology would provide investigators and stakeholders with a robust set of data for that. So, the sky is the limit. There is a lot of white space in the toilet monitoring your gut health. The reason being we believe is very difficult. What we have developed is technically very difficult to do because of the heterogeneity of the human stool. While urine, for example, early on in the development of the toilet, people asked as well are you doing a urine analysis toilet or are you doing a stool analysis toilet? And we reflected and our choice was very conscious. Urine is the liquid is not technically that difficult to have a urine analysis toilet and capability could be added on to our platform. We know exactly how we would do that. Stool analysis toilet is much more difficult because anything can come out of there from very hard to completely liquid and you have to capture it all because particularly the extremes are of interest. So, we tackled very deliberately, head on a very difficult problem. From an engineering standpoint, we believe we have solved it and now we are interested in having a product that will bring benefit to patients very soon.
Praveen Suthrum: Let’s switch gears to the business aspect of Coprata. So, what can you share with us about where you are as a startup, as a business? Where is the company currently?
Sonia Grego: The company is spin off of Duke University. We started with pre seed investment by enthusiasts and believers of smart toilet that have been supported our research and they nurtured it since it was at the university stage. We are making fast progress. Our team is growing headed by a CEO. We have completed pre seed round. We have raised funds from federal sources and other sources. We have won first prize as a new business venture out of Harvard Business School. So, we have received recognition for the originality and the potential impact of our approach. And of course, we are now raising funds again.
Praveen Suthrum: What is the product price at do you know already or is it still evolving?
Sonia Grego: We are still working on the pricing structure of the smart toilet, but it will be in the range of the existing smart toilet.
Praveen Suthrum: What is the business model? Is it mainly by selling directly to consumers or are there other types of revenue sources that you’re envisioned?
Sonia Grego: Our first step will be a direct to consumer. We believe that once the users expand and we have a base of users, we’ll be able to conduct studies and demonstrate the value to healthcare of the data that the system produces. So, once we are able to demonstrate the improvement in outcomes, the savings in time and healthcare costs that the data produces, we envision more of a B to B to C model in which payers and big employers will be interested in subsidizing or partially reimbursing the device for their patients the same way as it is done for diabetes. Now, diabetes is a chronic disease is far ahead than GI chronic diseases, but GI chronic diseases are pretty expensive and really impactful on the quality of life of a large and increasing number of people. So, we believe that large employers and payers will take notice of a system that enables remote patient monitoring with all the savings that come and then further out, our market can expand to stool sampling and medical grade devices that target specific population and the whole sampling analysis. So, our model starts with a clear focus, but it expands into many directions.
Praveen Suthrum: How far are you from a public launch of the product?
Sonia Grego: We are recruiting users for a pilot launch of our product later this fall and we want to have products for sale from our website in 2023 next year. So, we are very close to the launch of our first product.
Praveen Suthrum: One final question before I let you go. Given this journey, in your view, what is the future of a specialty like gastroenterology?
Sonia Grego: The future of gastroenterology, like of many other specialties, is in telemedicine. That’s what called it as push forward. And digital technology has developed. For this specialty, particularly where there has been no at home biosensor tracking specific physiological activity of the patient. We believe our toilet will be an important tool that will enable care that is remote, that is proactive and not reactive, and that will track patients in the long term to keep them in a state of remittance and health.
Praveen Suthrum: It’s quite an amazing innovation. I’ve never spent so much time talking about stool, leave alone a toilet. So, it’s been very insightful and it’s amazing to note your journey from biomedical engineer to the founder of Coprata, Sonia Grego. Thank you so much for joining today on The Scope Forward Show.
Sonia Grego: Thanks for having me.
Praveen Suthrum: It was great talking to you.
_
COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
button_download
07 Jul 2022

Patient demand is so high for GI psych – Dr. Riehl (Michigan) and Dr. Simons (Cleveland Clinic)

Patient demand is so high for GI psych – Dr. Riehl (Michigan) and Dr. Simons (Cleveland Clinic)
While COVID was on and people sought help through meditation apps, the business world of behavioral health made a big announcement. Headspace (an app started by a former Buddhist monk) merged with Ginger.io to create Headspace Health in a $3 billion merger. You read that right.
It’s only natural that behavioral health showed up in gastroenterology. Curious, I reached out to GI psychologists Dr. Megan Riehl from Michigan Medicine and Dr. Madison Simons from Cleveland Clinic. What were these large institutions up to in this space? Why were they hiring psychogastroenterologists? Was there patient demand for something like this? What role would cognitive behavior therapy play in digital health?
Well, this is an evolving space with high demand – especially for those GI conditions that don’t have straightforward solutions. Mental health and its role in the making and management of GI conditions is a space to watch. Explore if this could be a brand new ancillary for private practice GI. Well, the brain-gut axis has a significant role to play in GI’s future (watch this one)
What exactly is psychogastroenterology?
“I have over 100 GIs and trainees that can refer to our behavioral health program”
What GI conditions are treated by behavioral interventions? 
What kind of tools are used by a GI psychologist?
“The patient’s confidence to manage their symptoms gets better”
Are GIs open to GI psychologists?
“There are just over 400 GI psychologists worldwide” 
The evolving field of digital health in the realm of GI psychology
“I hope we can have a treatment that’s specifically designed for anxiety and fear around eating”
“GI OnDemand is a platform for patients to understand their conditions”
Latest research surrounding the brain-gut axis
“Whether you are a gastroenterologist or primary care physician, there are opportunities to receive additional training”

The Transcribed Interview:
Praveen Suthrum: Megan Riehl and Madison Simons, warm welcome to the Scope Forward Show. We are getting together a group of innovators, leaders who are doing things differently in Gastroenterology. And I’m really excited to have you. And we are going to be talking about a very important topic. Really looking forward to learning more. Thanks once again for being here.
Dr. Megan Riehl: Thanks for having me.
Dr. Madison Simons: Thanks for having us.
Praveen Suthrum: Before we get started, let me share your background with everybody.  Dr. Megan Riehl is a GI psychologist and Clinical Director at the GI Behavioral Health Program at the University of Michigan and Director of Behavioral Health Services for Gastro Girl and GI onDemand.  Dr. Riehl’s current interest focus on the application of digital therapeutics in GI. She participates on several national committees dedicated to research and education to enhance the psychosocial functioning of patients with GI problems. And Madison, you’re a GI psychologist in the esophageal and motility GI clinics at the Cleveland Clinic. Her clinical and research interests include understanding the determinants and consequences of dietary modifications in patients with digestive symptoms. Fantastic backgrounds, and I’m really glad to have this conversation. But I want to start with some basic, really basic questions about your field. So what is psychogastroenterology? It sounds very cool, but what is it?
Dr. Megan Riehl: It’s really great to be here and have this conversation with Dr. Simons and you Praveen. So psychogastroenterology is a field that has really evolved over the last couple of decades, but really we’ve seen an emergence of really exciting research around the application of psychological interventions for the treatment of gastrointestinal issues. So we call these interventions brain gut behavioral therapies. And it kind of encompasses the field of psychogastroenterology, where we work as expert GI psychologists, kind of fitting into a multidisciplinary approach with patients with a variety of GI conditions. So the bulk of the research has been done in kind of the functional GI world or disorders of gut brain interaction. But we have really exciting research that has been happening in inflammatory bowel disease, esophageal conditions. And so really, we’re finding that our treatments are pretty effective no matter where it falls in the gastrointestinal tract.
Praveen Suthrum: Does it have to be very specific to the GI tract? Could it not be broader psychology that might also apply to the GI tract?
Dr. Madison Simons: Absolutely. It could be underlying mental health conditions like anxiety and depression that could be exacerbating the GI symptoms.  But I’m sure Dr. Riehl can attest to this as well. If the underlying mental health condition is very severe, then our specific GI interventions are not going to be as helpful. So in that case, we would pull on a colleague who is trained to deal with anxiety or depression to address that first and stabilize it so that our GI interventions can be really targeted to the GI tract. I think we’re going to be talking about the patient demand for our services, and it’s so high just in addressing GI symptoms that we’re really better suited to use our expertise for the GI symptoms and allow other colleagues who are specialized in anxiety, depression, trauma to treat those conditions.
Praveen Suthrum: You’re saying there is a lot of patient demand for the services that you offer. Why and what kind of patient demand?
Dr. Megan Riehl: Well, I think we work in tertiary care clinics, and so I have over 100 gastroenterologists and trainees that can refer to our behavioral health program, and I started out as an N of one. And over the last couple of years, there’s now three of us full time, working to kind of meet the demand of our patients. And I think that once I started back in, I think, 2014 at the University of Michigan, once the program is built and established and providers begin to see the value that you bring in terms of helping to reduce healthcare utilization, patients that have been suffering with symptoms for decades that haven’t responded well to medication or even diet therapy, our behavioral interventions tend to be very effective for those refractory patients. And so in a fairly short period of time, anywhere from five to seven sessions, the patients get better. And so that kind of bumps up our referrals, and we form a very collaborative relationship with our referring providers and really work from multidisciplinary perspectives. And patients also find that to be really nice in terms of their gastroenterologist isn’t expected to fit all of the demands of a patient. We oftentimes run wait times, and that’s why, as Dr. Simons said, making sure that the appropriate patients are referred to us is going to help to kind of not not create any bottlenecks in our referral streams.
Praveen Suthrum: What kind of patients are you seeing or what kind of conditions are you seeing Megan?
Dr. Megan Riehl: A lot of patients with irritable bowel syndrome, inflammatory bowel disease, GERD, different esophageal conditions, it’s always fun to use. We have Esophageal hypnosis protocols that are really effective for functional Dysphasia Globus. So some of those really difficult to treat conditions our behavioral interventions can be really effective for, but also some of the gastroparesis, some of those patients are going to be appropriate for us. Some we’re probably going to refer out or really need to work within the context of integrative team. But you name it, we can probably add something to the treatment plan that patients are going to find valuable.
Praveen Suthrum: There are about at least six or seven encounters. What exactly happens in these encounters, and what is the care pathway looks like?
Dr. Madison Simons: Dr. Riehl has been with UOM for the last eight years. And that’s how most of the behavioral medicine programs are run, where all of the gastroenterologists can refer to you, and then it builds up quite a bottleneck of patients. I was brought to Cleveland Clinic to work with two gastroenterologists specifically, though I don’t know how long it will stay with just two. And their ideal model is that I would see every patient that they see, which also is not feasible for an N of one, because our sessions are longer, and we see them for more follow up sessions in a shorter period of time. But I’m working exclusively with patients with gastroparesis and Motility or Esophageal conditions. So both organic and functional conditions that are Motility related and Esophageal related and gastroparesis. So a typical model this is likely similar across centers, would be to see a patient for an intake evaluation about 60 minutes, where we go through not only the GI symptoms, but how those symptoms have impacted a patient’s quality of life, their ability to eat, their sleep, their ability to do the things that are enjoyable and meaningful to them and how their pain has affected them. And from there, we come up with a treatment plan, like Dr. Riehl said, anywhere from four to ten sessions or so. At Northwestern, we were piloting an intervention based on increasing psychological flexibility. We were actually playing cognitive games to get out the thought patterns that were affecting a person’s GI symptoms and how their GI symptoms affected their thinking. So the traditional cognitive behavioral model had patients monitoring their thoughts, monitoring their symptoms, and their emotional reaction to symptoms. And we used this in worksheets that we would get. And this is how cognitive behavioral therapy has been practiced for a long time. But this new intervention we were trialing at Northwestern, where we were playing games with the patients and identifying thought patterns in vivo in the moment proved to be very, very effective. And patients were very agreeable to it. They didn’t feel like they were in a psychotherapy session, and so there wasn’t the same resistance that we might see. But I’m not crazy, and it’s not all in my head. And in that treatment, we were actually working with all organic conditions and a functional Dysphasia group. But mostly this was Achalasia and Eosinophilic, Esophagitis and GERD. And we saw even improvements in symptoms in these organic conditions by identifying thought patterns and helping people challenge them to become just a little bit more flexible with how they view symptoms.
Praveen Suthrum: Are you doing this in a group, or is it always one on one?
Dr. Madison Simons: Its one on one. And we were administering it virtually via zoom, just like this to expand access. It was necessary because of COVID, to do it that way. Helped give us data that virtual treatment does work. But, yeah, it was all one-on-one sessions. We did it in a four-session protocol and saw improvements in symptom severity, quality of life, and symptom anxiety, which we’ve consistently seen as a primary driver in symptom severity across GI conditions.
Praveen Suthrum: You talked about using games. What kind of tools do you use? Are these developed by third parties? Do you just borrow what’s out there, or do you work on creating your own?
Dr. Madison Simons: The original game, so to speak, came out of what’s called cognitive remediation therapy. This was originally designed to build people’s cognitive flexibility. So we’re doing tasks like showing people an optical illusion, and then we ask them, what do you see in these images? What kind of strategies do you use to find more images? And then the question turns to you pay too much attention to one aspect of those pictures, you might miss out on other parts of it because there’s multiple things there. And so in daily life, are there times when you pay so much attention to one aspect of your symptoms or one aspect of your functioning that you miss out on the other parts of it? So it’s kind of guiding people through, seeing where their thought patterns and attention patterns may be impacting your symptoms.
Praveen Suthrum: Megan, now you’ve worked for several years in the field. What are the insights that you’ve taken away that have been surprising for you personally, having applied the field and seeing so many patients? What have you personally taken away?
Dr. Megan Riehl: Yeah, so as Madison is describing, the intervention that they’re using is really getting at the idea of helping patients to decrease their visceral hypersensitivity and awareness to their symptoms. And over the years, I’ve learned how just explaining some of that to patients is so powerful. So she also mentioned that sometimes there can be reluctance on the side of the patient if the idea of working with us isn’t clearly explained in terms of, okay, my gastroenterologist is referring me to a psychologist. Why? How does that fit in? We have done, and probably Madison and her colleagues at Cleveland Clinic, a lot of education of our referring providers on how do you explain when you’re making the referral to a psychologist, how that person is going to help the treatment plan. It’s not that you’re making up your symptoms. It’s not that you’re psychologically damaged. It’s that that psychologist is really going to help her hone in helping you to manage your symptoms in different ways. And so when the patient gets to us and we’re able to spend a session explaining brain gut dysregulation, and that when you feel your symptoms, it’s not that you’re making them up, it’s that they’re really real. But it’s that the communication between how the brain is picking up those symptoms and focusing in the serial hypersensitivity and hyper vigilance, and then your gut ramps up and sends signals up to the brain, and then we have just this loud, disregulated conversation happening. We’re going to work to decrease the awareness of those uncomfortable sensations using some tools and strategies, and we’re probably going to be able to reduce the frequency, duration, severity of your symptoms in a pretty short period of time. And so being able to watch our evidence-based interventions work over and over and over and even if a patient doesn’t have complete alleviation of their symptoms, their confidence to manage their symptoms get better and so personally rewarding as a clinician to watch people get better and to sometimes have them say, gosh, I wish I would have had this 30 years ago. I’ve been suffering for 30 years with these symptoms. Or and I work on a college campus to teach patients and work together to learn strategies that as they’re graduating from the University of Michigan and going off to do wonderful things in their life, that they’re going to have some really concrete skills that will help them live a healthier lifestyle. So I think that if you would have told me in my graduate training I’d be doing gut directed hypnotherapy and talking about GI issues for my career, I probably would have said you’re nuts. But I got into this field at a very early age in my career and it’s really just been fascinating and rewarding and exciting.
Praveen Suthrum: I’m curious from the gastroenterologist side, I get it from the patient benefits, but do you get now you have a wide stream of referrals, like over 100 GIs. So do you get referrals from the same GIs again and again or the other gastroenterologists? Is everybody open to it?
Dr. Megan Riehl: I think yes. So when I first started at Michigan and actually Dr. Simons and I both trained at Northwestern University, so it was a very established program. And so I took models of that to the University of Michigan, and they had never had a GI psychologist and a lot of places have never had a GI psychologist. So a lot of us that are doing this are coming in and doing program development and working on a business model and referrals and really is kind of field of dreams. If you build it, they will come because once one patient has some results and they see like, oh, wow, that person’s inbox messages decrease significantly, that works out for me pretty well. That certainly gets buy in. But I will say what’s been really kind of fun and fascinating is that we have a fellowship program and so our fellows are coming in with this very multidisciplinary approach. They can refer their patients to our GI dieticians. They can refer them to our GI behavioral therapist. They can refer them to a physical therapist. And so then when they’re going and they’re potentially looking at different places in the country, they come back and they’re like they’re not a psychologist. So when I’m thinking about my package and the hospital system I’m building in that I want to build a behavioral health program because we need that, especially if you’re a motility specialist. So it’s kind of fun. That the expectation for clinics or private practices that if somebody decides to go into private practice, they’re thinking about how do we either form connections with mental health providers in the community? That could be a referral stream for us until we potentially can get a GI psychologist. But it’s on the mind. It’s very much now kind of this expectation that if you trained with somebody, you’re going to want that in your clinical practice because you can’t fathom that it wouldn’t be somebody that you could collaborate with.
Praveen Suthrum: How many GI psychologists are there in the country?
Dr. Megan Riehl: Just over 400 worldwide. The Rome Foundation has a special subsection of psychogastroenterology. So we do have a provider directory and they vet kind of who goes on the directory based on expertise. And there are just about a little over 400 members around the world. So not enough when we think about there’s 40 million Americans with IBS, and that’s just those with a diagnosis.
Praveen Suthrum: Both of you work at really large institutions that also do a very good job administratively. So my question, Madison, and we can start with you, is it obviously has to make business sense for a Cleveland Clinic or for the University of Michigan, right? So how does this make business sense? As in, do you get reimbursed for these encounters? Does it make up for the other types of reimbursements that the hospital could be getting? So what does that look like?
Dr. Madison Simons: Megan would be able to give more specific numbers to this. But I know at the Cleveland Clinic, they do have one psychologist who preceded me here in inflammatory bowel disease for the billing for that person. It covered salary, office space, all those things, the amount that he was reimbursed for care. But the peripheral effects is that it decreased hospital admissions related to inflammatory bowel disease. It reduced emergency room visits and reduced the amount of outpatient visits for these patients who were involved with the psychologist. And so established value within the medical care isn’t tangible to just directly what’s being reimbursed by the psychologist. At Cleveland Clinic, I’m working with the surgical transplant team for Dysmotility patients. And so we’re hoping we’ll see value in that way and have even been incorporating hypnosis into colonoscopy to reduce the amount of medications needed during conscious sedation for patients, to make this better patient experience and reduce the costs associated with that.
Dr. Megan Riehl: Yeah, I think Madison is highlighting some of the there’s a lot of different places where we can see value. The nuts and bolts that I think a lot of administrators want to know, though, is are we going to run in the red? And they don’t want to carry that for too long. And the reality is, in a lot of the programs, especially if we are purely clinical, most of my colleagues do not do research at Michigan, and so we are seeing a high volume of patients and their insurance covers it. So in most cases, we’re seeing patients that are not paying out of pocket. It’s covered by Medicaid, Medicare, private insurance. And so, you know, we’re covering salary space. Quite frankly, we’ve been virtual for the last two and a half years. So I’m coming to you from my living room office that I’ve been seeing patients in for the last, however, march 2019 or 18, no, 2020. It’s something that we can cover our costs, and patients are also able to get it covered in most cases. Now, granted, state by state insurance coverage can vary, but the majority of the other programs around the country are utilizing a similar model for at least the clinical side of things. And then a lot of GI psychologists also have some carved out time that maybe they’re covered under research. So they’re maybe 60% clinical and 40% research. And so then they’re applying for grants or working under somebody else’s grant to cover the rest of their salary and time, especially in the private practice sector. They probably wouldn’t be doing research, and you’d be seeing a high volume of patience and likely covering your whole salary.
Praveen Suthrum: Talking about business models, it takes us into the realm of digital therapeutics. And there are a lot of digital health startups that are taking advantage of cognitive behavior therapy. And the way I observe it is it’s being packaged into an app, or people are there behind the app or behind the digital model itself. FDA, for its part, has been approving some of these therapeutics as well. And we see some examples of that even in GI Mahana Therapeutics, for example, that’s a company that comes to mind. There are others in the pipeline. What I’ve also found fascinating is a gastroenterologist wrote a book called VRx, and it’s virtual reality therapy. And when you actually dig a little deeper I’ve interviewed him, and when you dig a little bit deeper into VRx and why some of these applications are getting approved by FDA, it’s all, again, cognitive behavior therapy packaged very differently. Again, as a lay person, that’s how I’m reading this. I’m curious to know what you can share about this evolving field of digital health in the realm of GI psychology.
Dr. Megan Riehl: I think there’s so much promise in the use of digital therapeutics, but it’s very much it feels like we’re kind of building the plane while we’re flying it right now. That it’s happening, it’s out there. But the model of how and who we get patients who is the right person for digital therapeutic, how do they get it? Because you’re right. Mahana IBS is a very different model from a Nerva. Both treat IBS. Nerva uses gut directed hypnosis, and anybody can download it from the app store. Mahana IBS is a prescriptive. So in order for the patient to get that digital therapeutic app, the gastroenterologist has to write a prescription for it, and so insurance will cover it. And again, that’s really cool. It’s a really cool business model and I think it’s really attractive to patients. But we now as GI psychologists and as a field of psychogastroenterology, we have more education to do in terms of a patient that’s not appropriate to see Madison or I in person because they have untreated mental health symptoms or a trauma history or substance abuse. And they really will benefit from establishing with a comprehensive mental health provider to stabilize those symptoms. That patient really should not be prioritized to a digital therapeutic. And so if they can get their hands on it, though, and they’re coming to the gastroenterologist saying, hey, should I use this? Like, what do you think? We have to educate the gastroenterologist on this. So we’ve been educating gastroenterologists on what we do as GI psychologists since the beginning, and we continue to do that. And it’s fun and it’s actually something I enjoy in terms of talking about how can we collaborate together, and especially for patients that have been suffering. So I think this is just another area where we’re going to be a part of these conversations and working together with the digital therapeutic companies to help them understand this space. Because a lot of times they’re not necessarily GI psychologists that are putting this together. They’re consulting with us. But so far, in my experience, these companies are very open to talking with us who are really in the trenches of delivering these interventions and have a very good understanding of the patients that we’re using our brain gut behavioral therapies with. So, you know, long story short, it’s really exciting and innovative and unnecessary thing when it comes to improving access for our patients. But we still have a lot of work to do in terms of getting the right patients into utilizing these therapeutics.
Praveen Suthrum: So where is the field going? What do you anticipate seeing in the future?
Dr. Megan Riehl: I think Madison is the future. I think the work that she’s doing is innovative, it’s exciting, it’s engaging with patients. Tell us where you’re going because that’s where I want to go.
Dr. Madison Simons: I think the biggest challenge from here is that there are so few of us. And so what I’m hoping to do at Cleveland Clinic is starting to develop a triaging model that really cycles. Who is the most important patient that we can see that I’m not the only one having patients referred to me? Are there different ways that we can provide services to people? My interest area is also in the dietary modification patients. Almost every patient that I see has changed their diet in some way, and my interest is in the metabolic consequences of that. So, yes, the behavior, we perceive that as normal. That would be a very normal reaction to vomiting all the time, having a lot of diarrhea. I think you would do the same thing and so normalizing that behavior, but helping patients reestablish what is nutrition that’s going to support me? Can I develop different flexibility around eating? So like right now I’m looking at blood sugar and Glycemic variability and inflammatory bowel disease and how that might be related to symptom severity. So looking at now, okay, the diet has been modified and what are some of the downstream effects of that? Outside of just weight loss or nutritional deficiencies, which may only come out in some people, we know that many more people are changing their diets. That’s the direction that I’m headed. And I hope that we can have a treatment that’s specifically designed for anxiety and fear around eating. A good amount of literature on avoiding restrictive food intake disorder, but I see it as a little bit different than that. A broader group of patients for whom it’s normative to change their diet. Can we still help them with that?
Praveen Suthrum: Megan?
Dr. Megan Riehl: I think that the innovation of digital therapeutics is certainly something that is happening. It’s unfolding right now, how that all shakes out. I’m still really interested and I think we’ve got a lot of work to do in terms of really helping to educate both patients and providers around. How to utilize these? And certainly I don’t think that those of us seeing patients in person or virtually, we’re not going to not have work to do. So I think that there’s a lot of marrying of different things that will help. For example, we typically see patients for that few sessions and having additional resources to help them over the long span of their life and helping to build lifestyle changes that are helpful for the management of their IBS or their IBD or gastroparesis. We want to teach them things that are sustainable. Also, I think with different insurance billing models that are changing fee for service and outcomes, I think that having tangible resources that patients have learned that they apply, that they see a value. I think that a GI psychologist fits very well into helping to deliver those deliverables. So I think that the role of the GI psychologist in terms of on the ground work, research, leadership, it’s really kind of endless how the psychology of a patient can be assessed and worked around in GI.
Praveen Suthrum: Any thoughts on how does one scale these efforts? Clearly the problem case is large. There are millions of people who need this and there are just a few of you, as you said, 400 worldwide. How does one scale something like this?
Dr. Megan Riehl: In my opinion, it’s digitizing some of the therapies and creating other resources, whether it be one of the programs I’m a part of is GI onDemand and we’ve put together different webinars to help patients understand their conditions. So it kind of takes concepts that you would get from a GI psychologist but can be disseminated to anybody that has access to the GI on demand platform. And from there also, we’ve created algorithms and pathways to help patients understand. Do they need general mental health? Do they need a GI psychologist? Do they need more comprehensive services? So not only can patients use those resources, but providers can. So our GI on demand platform is really something that’s trying to take ideas from a tertiary care program and bring them to any gastroenterology program in the country. So things like that, I think, are ways that we can scale some of the valuable information and the way we deliver it as GI psychologists. So examples of helping a patient understand their pain and why brain gut dysregulation impacts that and why a dietary modification or a relaxation based intervention is going to be helpful for them. Lots of different ways to kind of educate the masses, I think is one of the scalable solutions.
Praveen Suthrum: I wanted to ask you, what is the latest research surrounding the brain gut access? You keep seeing articles every now and then about it. What is the latest which is out there?
Dr. Megan Riehl: Well, what I’m paying attention to is microbiome. So looking at microbiome, looking at how it’s individualized and how do we work with that in terms of maybe developing more individualized treatment plans. So I think that there’s a ton of emerging literature and exciting research in the space of how the microbiome affects the brain gut access.
Praveen Suthrum: Any final words, Madison, from you and Megan?
Dr. Madison Simons: As it’s even come out in this conversation, but just like being on the ground, working with gastroenterologist, having come from Northwestern, now just starting at Cleveland Clinic, I hear every day what a value I contribute to the team as a GI psychologist. And so for private practice gastroenterologist, I just think there’s not even a question of what value could be provided if hiring a GI psychologist is something that you’re wanting to do from a financial side, from a patient treatment burden and just helping clinicians understand their patients more, develop empathy for those symptoms. It’s really rewarding for myself, but also the team that I work with. So just for any providers, I think you would not go wrong to include a GI psychologist.
Dr. Megan Riehl: Madison and I both, we went the training route, right? So we have a lot of training as GI psychologists, and that may not be necessary for every mental health provider that might be interested in working with patients with Irritable syndrome or inflammatory bowel disease. And so I think that even whether you’re a gastroenterologist or a primary care physician, there’s opportunities with general mental health providers where they could receive some training, some additional training through the Rome Foundation. They have excellent educational opportunities for continuing education. So I think that we also have to think a little bit creatively in terms of our collaborative relationships between gastroenterology practices and mental health. And so just because you might not find a GI psychologist like Madison or I, you certainly could bring value by forming really strong relationships with mental health providers in your area. And if they find, hey, I really like working with these IBS patients or I really like this. Knowing that the resources through the Rome Foundation are available can really be a win win for your practice, for the provider, especially for the mental health provider, because a pretty strong stream of referrals that if you connect with a gastroenterology practice. So it’s just another way to consider that there are additional options out there when it comes to collaborating.
Praveen Suthrum: So Dr. Megan Riehl and Dr. Madison Simons, thank you, both of you, for participating, sharing your insights today and throwing light on this very, very, very important topic.
Dr. Madison Simons: Thank you.
Dr. Megan Riehl: Thank you.
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30 Jun 2022

Matt Schwartz (CEO of Virgo): “Huge opportunity to add a digital layer to GI and endoscopy” (Interview)

Matt Schwartz (CEO of Virgo): “Huge opportunity to add a digital layer to GI and endoscopy” (Interview)
A few years ago I ran into Matt at one of the GI conferences. At that time, Virgo was taking shape as a storage system for endoscopy videos. With persistence and the right pivoting, it’s amazing what Matt and his team at Virgo have been able to do.
In case you wondered, they’ve captured 400,000 endoscopy videos and that number is growing exponentially. That’s a lot of data.
Virgo smartly partnered with pharmaceutical companies so that they can recruit right candidates for clinical trials. That led to a fund raise of $8 million with FCA Venture Partners and a soon-to-be-announced strategic investor.
Their Northstar goal is to change the standard of care by saving data. You’ve heard of the new adage: data is the new oil. With the advent of AI in GI, it shouldn’t be a surprise then that Virgo will dramatically influence GI care in the coming years.
Watch this one. You might discover a new data ancillary in your own endoscopy room.
What led to the founding of Virgo? Why GI?
Why did they pivot toward clinical trials and pharmaceutical companies?
The business benefit for providers
“The biggest challenge around IBD trials was patient recruitment”
“We’ve captured 400,000 endoscopy videos and that number is growing exponentially”
“It’s crazy that we record 4K videos with our iPhones but don’t capture data of our most precious asset- our bodies”
“We have a lot of runway in the IBD space, but there are other disease areas within GI that we are looking at”
Medical malpractice implications of recording videos
“Video evidence can be a great tool of protection for endoscopists”
“Data is the new oil”
Virgo raised $8 million
“There is a huge opportunity to add a digital layer to GI & endoscopy”

The Transcribed Interview:
Praveen Suthrum: Matt, it’s great to meet you here on The Scope Forward Show. I want to warmly welcome you today, and I’m so glad to have this conversation with you.
Matt Schwartz: Yeah, thanks so much for having me. I’m a longtime fan. I know we’ve been in touch for a number of years now, so it’s great to be here.
Praveen Suthrum: So let me start by introducing you to everybody. So Matt is the CEO and co-founder of Virgo a digital health start-up that uses machine learning to automatically capture endoscopy videos and accelerate clinical trials. Matt has a degree in biomedical engineering from Vanderbilt University. Before starting Virgo, Matt led product management teams in the minimally invasive spine surgery and robotic surgery fields. So that’s quite a switch from spine and robotic surgery to endoscopy video recording. So tell us the backstory, Matt. How did all this happen?
Matt Schwartz: It’s an interesting story. I don’t know that I would have predicted ending up in the GI space, but it’s been a fun journey to get here. When I was at Intuitive Surgical, in particular, working on the Da Vinci robotic surgery system this is back in 2015, I became really interested and passionate about machine learning and computer vision and felt like there was this whole untapped potential for bringing machine learning systems into the world of video based medical procedures and felt like it was a waste. There’s an incredible amount of video data being generated in these procedures that nobody was capturing, and if we could only start capturing it, we could build all the really compelling machine learning to go on top of it. That’s what led me to leave Intuitive and start Virgo. And in the very earliest days of Virgo, we were actually primarily thinking about capturing video from surgical specialties. So in the earliest days, I was speaking with all of the orthopedic surgeons and neurosurgeons and colorectal surgeons that I’ve worked with over the years, and there was some interest in video capture, but it was not the intense sort of interest that you need for an early stage startup. It wasn’t the right product market fit at that time and started doing a little bit of background research and recognized that within GI Endoscopy from a procedure volume perspective, it absolutely dwarfs all of the surgical specialties. Maybe it doesn’t get the same level of attention as surgery does, but from a volume perspective, there’s just an incredible amount of health care going into GI Endoscopy. So actually connected with the dad of a childhood friend who’s a gastroenterologist in my hometown of Indianapolis. He said, there’s this doctor, Doug Rex. He’s right down the street. Actually, Dr. Rex’s endoscopy center is about ten minutes from where I grew up. He’s one of the world experts in colonoscopy, and you should really speak with him. I think he might be interested in video capture. My co-founder, Ian, his dad, was also seeing his gastroenterologist at the time, David Cave, up at UMass. And between the two of them, they gave us a lot of encouragement that GI was really a specialty to look at. We ended up going on Dr. Cave’s recommendation to the Aga Tech Summit back in April of 2017 and just met a bunch of really forward thinking gastroenterologists who thought what we were doing is really interesting, and that, more than anything, pulled us into the gastroenterology space. So an exercise in kind of following the voice of the customer and just seeing where things led us more so than us having any bright ideas of our own and figuring that GI is the place to be.
Praveen Suthrum: Very interesting. Now I recall the last time we met in person, you talked about Virgo as an Endoscopy video recording system. Somewhere along the way, I see that clinical trials have been added, and I’m assuming it was a pivot that you made during the last couple of years. Tell us about it.
Matt Schwartz: Yeah, I think when we look at Virgo, our core competency is certainly in building automated video capture infrastructure and doing that in a cloud based fashion. We still feel like there’s a ton of potential to help Gastroenterologists and Endoscopists in general, easily capture their video data. So that is what the entire Virgo platform is built on, making it really easy to capture high quality Endoscopy videos. In the earliest days, we were selling that as a software solution to hospitals and health systems around the country, and built up a nice business in doing so. But the long term value of the company, we always believed, would come from the data that was being captured and building additional tools on top of that data. Just before COVID really kicked in, we started exploring the pharmaceutical clinical trial space, and again, this was actually largely driven by our key customers, many of whom were principal investigators on pharmaceutical trials, a lot of them in the IBD space. And we were hearing over and over again that the technology available to help facilitate IBD trials is pretty lackluster. And there’s this whole component of IBD trials around Central Reading, where it’s an interesting case where you actually have to capture the video data for patients that are part of the study. And doctors were required to use these pretty challenging to set up laptop systems. They would come in and try to plug everything in the day of the case. Then the laptop would get shipped around the world for the central reading. And so the PI’s were telling us to be great if you could do something around central reading. So we took it upon ourselves, just make a bunch of contacts with pharma executives and innovation leaders in the pharma space. And what we heard was that the central reading was certainly a problem. But the biggest challenge around IBD trials was in just recruitment of patients into these studies. For IBD studies, a big phase three study might take 500 to 2000 patients to fully enroll. And if you look at the data on your typical, even high performing IBD trial sites, they’re only enrolling about a patient per year on average. And so the pharma companies end up having to onboard several hundred sites around the world. Many of those sites actually failed to produce any patients for the study. And the studies still take multiple years to actually get completed. And the impact of this is huge. It’s delaying drugs from reaching patients. There’s a huge financial impact on the pharma companies. Every day the drug is in trial and not on the market, they’re missing out on a ton of money. We started to just think a little bit more deeply about this problem, talk to our advisors, principal investigators, to figure out what some of the root causes were around these low recruitment rates, and ultimately discovered a huge part of it is around screen failure during endoscopy. We kind of put our heads together and realize that the data we’re capturing in endoscopy video and just standard of care encounters can be really powerful as a tool to find the right patients for the right clinical trials. So it was a business model pivot kind of driven by the market need and the fact that pharmaceutical companies, there’s just a ton of opportunities for digital health companies to work with them. And I think in a lot of respects, they can make a better early customer than hospitals and health care systems just based on the amount of capital that they have to deploy into new solutions.
Praveen Suthrum: So are your customers, are your current customers pharma companies?
Matt Schwartz: It’s both pharma companies and healthcare providers. So at the core of what we provide, it’s still really important that we’re helping gastroenterologists to capture their endoscopy video data. Part of the value that we add to a clinical practice is that they can use Virgo for all the great things they can do with their video data. Doctors can build up their libraries, use videos for research projects, training with residents and fellows, quality improvement. We have doctors that actually share videos directly with patients as a patient engagement technique. And so we want doctors to be able to get value on a day to day basis from Virgo. And we think that’s a really important part of the solution. And then our other set of customers are the pharmaceutical companies where we can help them to accelerate clinical trials. We’re actually doing a bunch of other work around trial site selection and optimization, starting to get into the central reading space. We think the platform can really be a central hub for not just IBD trials, but other GI trials going forward. So it’s almost like a two sided marketplace now where we’ve got on one side the provider groups, on the other side the pharma companies, and we’re a technology solution in the middle that helps to optimize the integration between the two.
Praveen Suthrum: I just want to understand this a little bit more. So it is not necessary that the physician on one side and the pharma company are connected, right? It’s separate.
Matt Schwartz: That’s right.
Praveen Suthrum: Two different business units, if you will. So it’s the same solution, but it’s being applied and utilized for different purposes on either side.
Matt Schwartz: Exactly. So it’s the same. The core video capture infrastructure is at the foundation of both sides of the equation there. But the actual features and tools that we put in front of the users are slightly different. Whether it’s a doctor looking to use Virgo to capture ERCP cases for presentations, or if it’s a pharma company that is working with us to help accelerate their clinical trial recruitment or platform that gets installed in the endoscopy suite is the same across the board.
Praveen Suthrum: On the physician side, on the gastroenterologist side. What are they paying you for and what is the business model there?
Matt Schwartz: The fundamental business model is around video capture and video access. So we have an annual software fee that we provide, so we’ll include the hardware as a loaner. There’s no additional charge for the hardware. And with that annual subscription fee, the health system receives unlimited recording, unlimited storage, unlimited user accounts, and unlimited data access. So we’re very motivated to get doctors recording not just some of their procedures, which I think is how things have been done in the past. You recorded very rarely. We’d actually like to motivate people to record every single procedure that they have. And so we’ve set up this model where it’s just fully unlimited. We install the devices for interventional. Advanced endoscopy suites will actually set up multiple devices so you can record endoscopy, fluoroscopy, spyglass, endoscopic ultrasound, all from the same room in the same procedure simultaneously. And again, you can do that fully in an unlimited capacity. And then at the same time for health systems that are interested in getting involved in our clinical trial solutions, working with some of our pharmaceutical partners, we have discount programs that can actually dramatically reduce the cost of Virgo to the provider. And we’re able to then monetize by working with pharmaceutical companies.
Praveen Suthrum: So I get the benefit from training and education from that standpoint. Is there a business benefit for providers to record video?
Matt Schwartz: Yeah, I think there are certainly some indirect business benefits to just improving overall quality training programs are certainly motivated to have higher quality training tools for their trainees. One of the big business motivators has actually been around clinical research on the provider front, too. As I’m sure you’re familiar, whether it’s in private practice or in academic groups, there is a lot of motivation to have high functioning research organizations within those groups. And for GI practices that can run efficient clinical research groups with limited overhead can actually become a profit center for what they do, because the Pharma companies, again, are highly motivated to find sites that are good at producing high quality patients for their trials. And so what we can do for the clinical trial sites, the healthcare providers, is help them find more patients within their pre existing populations that are good candidates for research, and we can do that without them having to add additional overhead. I don’t know how familiar you are with clinical trials right now, but it tends to be a very manual intensive process where you have to hire skilled clinical research coordinators, and certain clinical research coordinators have more experience than others. They’re better at finding and selecting patients and administering these trials. And it can be a lot of overhead. I know there have been some groups, especially in private practice, that have tried to spin up clinical research arms and have struggled to do so. They end up spending a lot on overhead and not actually producing much in terms of patient enrollment. And when they do that, they’re not being compensated by the Pharma companies enough to support the overhead. So we can basically be a free tool that helps them drive a more profitable research center within their practice.
Praveen Suthrum: From the point of view of the pharma companies you’re helping recruit patients for, let’s say, IBD trials, how exactly does the system identify that so and so patient is suitable for this kind of trial? What is in the system that is able to identify this?
Matt Schwartz: Yeah, great question. So IBD trials, they’re a great case study to focus on. They have some nuances to them that make them perfectly set up for this. But we think the similar process will apply for other areas in GI and actually, outside of GI that we’re looking at. Speaking about IBD as an example case for ulcerative colitis and Crohn’s disease trials, there are very specific endoscopic scoring criteria that a patient must meet in order to be eligible for a trial. And if you look at the typical workflow for finding a patient for an IBD study, typically it happens when the principal investigator for the study who’s one doctor within a practice. If it’s a large super group, it could be 100, 200 physicians within the practice, there’s really only one doctor who’s the principal investigator. That physician is generally pretty good about evaluating their personal patient population. And if they catch wind of a patient that they are about to see in clinic that they think might be a good candidate for a trial, they’ll approach the patient and say, hey, we think you may be a good fit. We need to get you a colonoscopy to see if you meet the endoscopic criteria for this study. A lot of patients don’t want to go through an unnecessary colonoscopy, and so the ones that do, they will show up, and you have to hope that the patient does, in fact, meet the right scoring criteria. The screen failure rates on endoscopy, we hear, are in the range of 50% to 70%. So you get a ton of patients that show up, they get this colonoscopy, and they don’t actually meet the criteria. It’s a pretty terrible experience for the patient generally, not great situation for the clinical research coordinator, who puts in a ton of work only to have all these failures over and over again before they get a patient finally enrolled. What we do with Virgo is actually just focus on capturing every single standard of care colonoscopy that’s taking place as part of a patient’s normal journey. So if you have an IBD patient and they’re going to see whoever their physician is, they get an endoscopy. And we’ve developed some machine learning, we call it Auto IBD, that’s creating a predictive score that’s not diagnostic in nature. So we’re not trying to say what the Mayo score is or the simple endoscopic score for Crohn’s disease. We’re simply using this as a triaging score. And so the higher the score is, closer it is to one, the more likely we think this patient is going to be a good candidate. And we create a threshold and start automatically sending those patients to the clinical research coordinator. One of the areas where this gets really impactful is within a large practice. Even though there’s only one principal investigator on the IBD study, most of the partners within the practice do have some level of an IBD patient population. And so we’re helping those doctors for the patients to the principal investigator without having to actually do any extra work. Most doctors, if they’re not the principal investigator, they don’t really know what’s going on from a research perspective. They don’t know all the details of the study. And we can help them automatically identify patients in their population and get them referred over to their partner who is the principal investigator on study. The best way to think about it is almost like flipping the paradigm with recruitment to using standard of care data, which is the video of the endoscopy as the first step in finding the right patients and then getting them into the research pipeline from there, as opposed to just focusing on any patient and hoping and kind of crossing your fingers that their endoscopy is going to meet the criteria.
Praveen Suthrum: Now, these videos. Out of curiosity, how much of video data is generated in GI on a given day, month year? I’m sure you some analysis on this.
Matt Schwartz: Yeah, we’ve done some analysis. I’m a little rusty on the exact numbers. It’s actually challenging to get great numbers on how many GI endoscopies are done in the US. Every year. We’ve seen estimates that range from 15 million to upwards of 50 million On an annual basis. I think the right number is probably around 25 million GI endoscopies or so. And we see within our data set, we’re now coming up, I think, on about 400000 GI endoscopy videos that we’ve captured. That number is just growing almost exponentially. We’ve seen that the typical GI endoscopy is about ten minutes in duration. You’ve got some really short upper endoscopies, you’ve got some really long ERCPs, and then you’ve got some standard colonoscopies there in the middle. So we see about ten to 15 minutes for a typical GI endoscopy video. Now, in terms of how much data is being generated, the question gets a little bit nuanced because it depends on what quality you’re saving the data at, what sort of data compression you’re doing. We try to be really intelligent about our data capture to make sure that we’re minimizing storage costs, but also preserving really high quality video data. So what we see on our end, the way we’ve set up the Virgo platform, it’s roughly one to one and a half gigabytes per hour of endoscope footage that we capture. So it’s a lot of data, and there’s a lot of data that still is going uncaptured today. And one of our North Star goals is to just change the standard of care. We think it’s a shame in 2022 that there’s so many videos that aren’t being captured. Kind of crazy. You can walk around with an iPhone and record basically unlimited 4K video of anything you want. And for some reason, in healthcare, our most precious asset, our health, our bodies, we’re not saving this data. It’s a little bit crazy to me.
Praveen Suthrum: So 400,000 videos, that’s a lot of videos. Who owns this data?
Matt Schwartz: Yeah. So our customers, the healthcare providers, own their data, and that’s really important to us. There’s a lot of incredible potential applications for what can be done with this data. And we want to make sure that our customers are at the forefront of using their own data, whether that’s for research, training, whatever it might be. We also have a number of academic partners who are leveraging their own data that they capture in Virgo to build their own artificial intelligence tools that they’re using, looking to license, and we want to support that. Now, with our customers owning their data, they grant us a license to use the data to provide it back to them in the platform and make improvements to our system. It’s a pretty typical SaaS agreement that allows us to just furnish the actual services and make sure they can view their videos in the cloud and then make improvements over time with that data.
Praveen Suthrum: So when you say license agreement, you pay them for using the videos?
Matt Schwartz: No. So as part of our customer agreement, we’re granted a license to leverage the data. Again, it’s a typical SaaS agreement where in order for us to just even have a portal that they can access, we need a license to put their data back into that portal so that they can actually use the Virgo platform.
Praveen Suthrum: What are your growth plans? Are your growth plans going to largely come from healthcare providers and pharma companies or are you going to go beyond it’s a two sided growth plan?
Matt Schwartz: Certainly our goal is to get Virgo into as many endoscopy suites eventually around the world as possible. We have some plans right now, starting pretty soon and into later this year, to start expanding internationally, both in Latin America and the EU, I think also looking in Asia later this year into early next year. So that’s one side of the equation. It’s just how do we get Virgo into every single endoscopy suite around the world? And a lot of that is coming just through organic growth. We’ve been building out our internal sales team. We also are starting to see some really positive network effects from the platform where we get doctors actually sharing videos with their colleagues at other institutions that don’t have Virgo. And it’s a great reason for us to follow up with them and try to understand if there’s an opportunity to bring Virgo to their practice as well. And then we are starting to build out strategic partnerships. We are taking on a strategic investment from a major endoscope manufacturer that will be able to announce your shortly and working on some commercial relationships with them as well that will help to rapidly scale up our distribution. So that’s one side of the equation. It’s just get Virgo out into the field in as many places as possible. And on the other side is trying to work with as many pharmaceutical companies as possible. We’ve got a number that we work with today and are looking to expand those relationships. We’ve talked about patient recruitment as a major part of what we offer to pharma companies, but again, we’re starting to expand our scope of solutions with pharma companies as well, where we can actually help them identify, optimized clinical trial sites based on historical data that we’ve captured at certain locations and then pick the best sites that are already up and running with Virgo. Then we get into patient recruitment as well as central reading as part of the full solutions that we can offer with the Virgo platform. One thing that’s maybe interesting to talk about on the pharma side is there’s a ton of focus on IBD, the gorilla in the GI pharma space. We’ve got a lot of runway in the IBD space, but there are other disease areas within GI and actually beyond GI that we are looking at now. Eosinophilic Esophagitis is a hot up and coming area for GI pharma, acid reflux, colorectal cancer trials, gastric cancer trials. We think all of these, any trial that could potentially involve Endoscopy in the continuum of care, we think they’re going to be great opportunities for Virgo to expand. And then outside of GI, we’re starting to look at pulmonary and urology studies where we’ve actually started capturing a decent number of bronchoscopy videos at a number of our sites and we’ll start looking to capture cystoscopy videos here in the near term as well.
Praveen Suthrum: Aren’t the doctors concerned that all their video is being captured? Because the medical industry is one of the most regulated and physicians are one of the most regulated professionals out there. Right? So there are point of time, seven or eight different bodies looking at every little thing that they do. I would suspect one of the concerns Endoscopists have would be that their data is now out in the open and it’s for everybody who wants to see, and if they may be well meaning. But let’s say that something has gone wrong now, that data is forever captured for eternity and it’s out there in the cloud somewhere. Isn’t that a big concern?
Matt Schwartz: It’s probably the first major objection that we faced when starting a company. My dad is actually a spine surgeon and so I told him I was thinking about quitting my job and I wanted to start this company where we’re going to record every video that the doctors create. And I thought he’s going to reach through the phone and try to strangle me. He’s like, I don’t want my videos recorded. This is a terrible idea, it’s malpractice implications. And I certainly understand that sentiment and we’ve interacted with that sentiment quite a lot. But I think there’s a bit of a sea change happening where I think people are seeing the other side of the story and from our side. We did a ton of research in the early days to figure out what were the actual liability implications and what this involved. For me, I actually did a whole deep dive into the medical malpractice insurance industry and spoke with experts from medical malpractice insurance companies. And if you talk to them, it’s really interesting what drives the cost in medical malpractice. And it turns out about 60% of their costs are paid in legal fees and the other 40% is what gets paid out to patients in eventual settlements. So they actually spend more money going to lawyers than what goes to patients as part of malpractice suits. And when you speak with them, they’re really motivated to find ways to reduce those legal costs. And one of the best ways to do it is just by settling cases early. Now, with malpractice in most states, you need to have both evidence of negligence and harm. There can’t just be harm done. There has to actually be negligence. The doctor not following the standard of care and what most malpractice insurance companies feel also if you talk to experts who are providing expert testimony, they feel like video evidence can be a great tool of protection for endoscopists. If you’ve got a video showing that the doctor performed a standard of care endoscopy, there’s basically no better way to go to a judge and say, listen, the doctor performed standard of care, this case needs to be dismissed. Or if the video does show that there was true negligence, not just that there was harm or something was missed, but the doctor did two minute colonoscopy and there’s no way they could have possibly done a high quality exam. The malpractice companies would actually rather just settle that case early as opposed to drag it out over five years and rack up legal fees. And so we’ve actually had malpractice insurance companies that are willing to offer discounts on malpractice premiums to practices that implement Virgo across the board to record all their videos. And we think that’s the way of the future. There’s article that was written by Doug Rex where he talks about in radiology, the entire MRI exam is captured. It’s not like you just saved the slice that has the actual diagnosis. They’re really good about documenting everything. And he explains in this article that he thinks the best way to protect yourself as an endoscopist is to have a high quality video recording. And if you’re doing a good job, that video is going to be much more likely to protect you than hurt you over the long term. So it’s a conversation that comes up all the time. I have noticed in the five years since we started the company that I really think things are moving in this other direction where people see this as protective in the way of the future going forward.
Praveen Suthrum: There are a lot of AI companies starting up in healthcare and in GI in particular. One of them went through a huge fundraising cycle recently. I would think that a lot of these companies would actually be interested in video data to apply computer vision, to detect the polyps, classify the polyps and do whatever they’re doing. That seems to be one growth opportunity as well. I’m sure you’ve considered it.
Matt Schwartz: It’s a very active space. I think the investment that we’re seeing flowing into digital health companies in GI specifically around AI, there’s just a lot of motivation to figure out what the future is going to look like five or ten years from now. And I think we’re still in super early stages, like GI genius on the market, but I don’t really know what the future is going to look like from an AI perspective. What sort of clinical diagnostic tools are actually going to receive reimbursement? I think it’s going to have huge impact from our perspective. Again, our core competency is capturing this data. And we are receiving more and more inbound from companies that are focused more on the AI algorithm development, who are hungry for not just data, but actually a platform where their algorithm can be deployed. From the very beginning days of the company, we wanted to provide a product.Day one, as early as possible. We wanted to have a product that can be installed and add value to doctors. And by nature of doing that, we now have this platform where we build some AI of our own that we roll into the platform. But we’re very interested in what other algorithms from third parties, be it AI startups, larger players in the endoscopists that are building AI, or even academic partners that are building their own AI, we’d love to find ways to help them run their algorithms in the real world clinical setting. I think what we’ve seen a lot of is that a lot of AI can remain in the research phase for a very long time. Where you get these publications, it’s a cool proof of concept, but there’s not a clear path to actually deploy these systems out in the field. And so we think as part of having the pipe set up for the videos, it’s a great way to start deploying machine learning algorithms, too. So we’re exploring a number of possible partnerships in the AI space.
Praveen Suthrum: You’ve obviously heard of the phrase data is the new oil, so here we are. But the chokehold in the AI space is not the algorithm anymore. In the earlier years, it used to be the algorithm and the startups were all excited about creating a better AI algorithm that you can just drag and drop from an Amazon website.
Matt Schwartz: It turns out Google is better than everyone.
Praveen Suthrum: Yeah, exactly. And it’s free. So some AI algorithms are free. So that’s no longer the chokehold. The chokehold is data and clean data. Who can guarantee data. So I see a huge opportunity here where both endoscopists physicians on one side, providers can benefit through a partnership. And companies like yours that are making this data usable, if you make it, can benefit because this is exponential. I mean, it’s going to explode.
Matt Schwartz: We pretty early on felt like the algorithm was not the secret sauce here. And part of that was because I realized early myself, as not a machine learning expert, I was able to build these kind of interesting machine learning tools because there’s so much open source available technology out there. And so we felt like the real differentiators would be the data. But with the data, it’s important how much data you have, what the quality of that data is, how you can refine the data. And one of the things that I think is overlooked with data is how fresh the data is. The best AI technologies in the world, when you think about self driving cars or Google search technology. They don’t just have a small data set that’s stagnant, they’ve got a constant stream of ever refreshing data so that they can refine an algorithm, test it in the real world, see how it performs, and so they’re always being able to just move things forward. And so that was really important for us is how do we get data continually flowing in instead of just like we could have always gone and asked a few health providers capture 10,000 videos for us and then that’s it. But we felt like the continual pipes were the important part there. So I think that’s important. And then the other piece that I think is going to be maybe more important than anything is just figuring out the right business model around AI. I’m a little bit skeptical myself about where clinical decision support is going to fit in from a business perspective just because I worry about whether we’re ever going to see positive reimbursement for clinical decision support AI tools and whether that’s going to make sense. So I think that’s a big part of it. It’s just cracking the business model and the distribution piece as well with AI.
Praveen Suthrum: Let’s switch gears to the business aspects of your company. So, congratulations, first of all, to you and your team for the great fundraise. So what can you share with us about this fundraise?
Matt Schwartz: Yeah, so this is our Series A raise. We raise $8 million in capital, which we’re incredibly excited about. We’ve got a great lead investor group called FCA Venture Partners, which is out of Nashville, which is fun for me, my co founder, we both went to Vanderbilt Nashville, so it’s nice to have a national investor. And they focus exclusively on healthcare. They’ve got really deep networks with health care provider groups. They’ve also invested in a number of digital health companies that specifically provide software services to pharmaceutical partners. So they’ve been an amazing partner. The other thing we’re incredibly excited about with the raise I mentioned it before, is that we’ve got a strategic investor coming on board. It will be the first investment out of their corporate investment fund. I can’t announce who it is just yet, but we’ll be announcing soon. And we’re just thrilled to have them on board as a partner, we think not just from an investment perspective, but from a long term strategic relationship, it’s going to make a ton of sense and really help drive our growth forward. So with the Series A, it’s all about building out the team. We’ve already added a number of folks to the team through this year, and we’ll look to roughly double between now and the rest of the year, adding people to the sales and customer support side of the house, as well as building out our engineering team.
Praveen Suthrum: You have a bird’s eye view of the GI space, I must say. Right, so you’re connected to so many different practices providers. You’re seeing the industry from the Pharma side where everything is going. What is the future of GI from your lens as an innovator, as an engineer?
Matt Schwartz: Take everything I say with a grain of salt. I’m certainly biased in the space, but I still feel like there’s a huge opportunity to add a digital layer to what’s going on in GI and Endoscopy at large. I think there’s just, like, so many opportunities for software solutions to come in and help out, and I think we’re still in the very early stages of doing so. We’re pretty friendly with a number of digital health companies like SonarMD and Oshi Health. And I think what they’re doing is incredibly compelling and starting to bring the patient experience much more into the folds when it comes to software. So I think we’re going to see at some point, like the next five years, a digital layer emerge on top of what’s happening in Endoscopy that goes well beyond just Endoscopy report writing. When I look at the EHR is kind of the de facto digital layer of healthcare right now, and I’ve always felt like EHR is the term is kind of a misnomer. To call it an electronic health record is not doing justice to the term health in the equation there. They’re really electronic health billing records. Like, if you look at EHR is designed as a billing tool to facilitate optimal billing in healthcare. And I think there’s still an opportunity to build software that creates a proper health record, a clinical record that’s viable for clinicians to use in day to day clinical practice. So I don’t know if that exactly answers the question, but I think we’re going to get to a point where it’s not just hardware being used for Endoscopy, that there’s true digital tools on top of the Endoscopy stack.
Praveen Suthrum: Matt, it’s been a fantastic conversation. Thank you for sharing your perspective and being open about everything that I asked. Is there anything else that you wanted to share?
Matt Schwartz: This has been fantastic. Thanks so much for having me. I always enjoy your interviews that you post. I think you do an awesome job of just bringing together different minds from the industry and more than anything, love your willingness to put a controversial opinion out there. So, yeah, look forward to seeing more of your interviews and keep that up.
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COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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24 Jun 2022

Dr. Fehmida Chipty: From GI doc to COO of a digital health startup (Interview)

Dr. Fehmida Chipty: From GI doc to COO of a digital health startup (Interview)
I got to know Dr. Fehmida Chipty because of her involvement in NovoLiver, a fatty liver disease startup I cofounded in US and India. She’s a Boston-based gastroenterologist, and a photographer. As the months rolled by, I observed closely how Fehmida made up her mind to leave private practice GI and take the plunge into the vast unknown. After just a few weeks of exploration, she assumed the role of chief operating officer of NovoLiver transforming the startup’s operations. She brought order to the house.
GI doctors are conditioned to function the way they have for the last 10-15-20-30 years. But the industry is shifting gears. Technology and business forces are disrupting the norm as we know it. Physicians want to change but fear grips them as they do. Most don’t talk about their concerns openly fearing ridicule of their peers.
Watch Dr. Fehmida Chipty’s fascinating narration unfold fundamental issues of gastroenterology. As with Scope Forward interviews, I ask my questions quite directly. Why did she quit GI? What are the problems that we don’t talk about? Why don’t physicians ask for help? What her concerns are with our healthcare system? Is doing colonoscopy after colonoscopy really helping solve for cancer?
Your future self will want you to watch this one.
Why did Dr. Fehmida Chipty quit a thriving GI practice?
Journey from a GI doctor to COO of a digital health startup
What are the unspoken problems faced by GI doctors?
If the end game is to prevent cancer for a GI, are there more effective ways to do that?
“Female colonoscopies are more complex”
“Physicians don’t ask for help”
◘  The looming threat of disruptors like AI, digital biology, consolidation, patient mistrust and its effect on physicians
“If Physicians don’t adapt, they won’t survive”
If GIs and physicians leave the field, who will take care of the patients?
“I am scared about where GI and all of medicine is going”

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COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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16 Jun 2022

Abe M’Bodj: How will PE respond to recession? (Interview)

Abe M’Bodj: How will PE respond to recession? (Interview)
There’s a lot of noise about recession right now. Inflation is high. Job losses are on the horizon. Public markets are brutal. Abe M’Bodj, VP at Westcove Partners an investment bank helps us listen to the signal from the noise.
What I was curious about was the mindset of private equity companies during an economic downturn. Would they continue to invest in GI or hold-off? Or, would they accelerate their investments? (there’s a lot of “dry powder” available).
Talking about gastroenterology specifically, what would happen with upcoming exits? Would they continue to get pre-downturn valuations? What about bankers who gave debt in these transactions? How about the GI practices that didn’t transact?
If there were a crystal ball, what can we expect in the coming months with PE in GI?
This is one of those interviews that unpacks a lot of information and converts that into deeper insights. Listen or watch closely.
The ‘R’ word
What exactly is recession anyways?
“That’s like a textbook outcome of what to expect when you are printing money”
Where does private equity get its money from?
“The longest weekly decline in the stock market since the tech-bubble burst in 2000 was seen in the last month”
What would a PE firm be worried about at the moment
“Healthcare services are a great area for PE investments” 
…will likely see a secondary transaction next year
If Gastro Health were to exit at the peak of the recession, would they get the same valuation?
“10% of 14,000 GIs  are part of PE-backed organizations
“A lot of the slower-moving groups will be acquired by the larger ones”
“Where is GI in terms of PE right now”?
Crystal ball on upcoming announcements in GI?

The Transcribed Interview:
Praveen Suthrum: Abe, it’s really nice to see you again. Welcome back to The Scope Forward Show.
Abe M’Bodj: Likewise. Thank you for having me. For me, it’s good to be back again.
Praveen Suthrum: I want to introduce you to our audience. So Abe M’Bodj is currently a Vice President with Westcove Partners, an investment banking firm that specializes in working with healthcare entrepreneurs and has unique experience advising physician practices and more specifically, GI practices through private equity and or strategic M and A transactions. So Abe this is going to be such a useful conversation for people who are listening, because I’m going to start with the R word, which is recession. So are we in recession? Is this supposed to be recession?
Abe M’Bodj: I have to check the exact I think the specific definition of recession is two consecutive quarters with shrinking or negative GDP growth.  I don’t know if we’ve met the technical definition for a recession yet, but it definitely feels like economic activity is declining, maybe a little bit. I know everyone’s sort of waiting on some updated inflation numbers and data, but I think as a result of some of the kind of monetary and fiscal policies of the last year to pump a lot of money into the economy, you certainly had inflation pick up, which has caused a lot of prices to increase. Gas, grocery store, used goods, all sorts of items have kind of increased in price. And so it’s caused consumers to pull back a little bit on spending and definitely slow down economic activity. And then there’s been obviously a lot of talk of rate increases, which is also hampered a bit of activity as well, which has a direct impact on private equity and their investments into various various companies and organizations. But I don’t know if we’ve hit the technical definition of recession yet, but activities definitely slowed down from an economic standpoint. I think from a deal standpoint, just kind of seeing transactions on a day to day basis. There’s still quite a bit of activity in the market. Private equity firms are still deploying a lot of capital, partially because you look back at prior economic slowdowns or prior true recessions in the same span of time. I was actually looking at this a little bit earlier today. From 2011 to now, the amount of private equity capital that’s available from deployment has increased from about 1.1 trillion to about $2.9 trillion across the industry. So as you think about sure that there may be a little bit of slowdown rates may be increasing, which makes it more expensive to deploy capital and finance deals. There’s also so much more dry powder, as we call it, or capital available for investment in the industry that you’re still going to see quite a bit of activity because the funds have to find ways to put that money to work.
Praveen Suthrum: Okay. So you packed a lot of information in that response. So I want to break that down a little bit. So let’s start with the basics. So we don’t know whether we’re in recession or not, but it smells like one. Technically, we don’t know yet. But if you were to explain to an eight year old what exactly is the problem with recession environment, how would you say it. Like costs are going up, inflation is high. That means that everything is more expensive. But then you’re also saying there is more capital available. But I would think that there’s less money available. But I want to hear from you. How would you explain it? In very simple terms.
Abe M’Bodj: Yeah. So I think in terms of what a recession is, it’s a general again, decrease in economic output or GDP, meaning the value of goods and services in the economy is decreasing. And so when I say how inflation is impacting that as normal day, everyday people like ourselves go to the grocery store or go to fill your car, the gas pump, the price of those things are increasing. And so I’m in Southern California, so gas is easily well over $6 gallon. Many gas stations here. You go to the gas station. And that cause you to think twice about going to that nice dinner you wanted to go to or that elective procedure in relative health care that you may want to have on a micro level. Like these things don’t seem to be correlated, but there is a general correlation with the level of inflation and consumer price increases and the level of consumer spending that goes into the economy. So circling back to what that means for an eight year old, I guess people are spending less money than they have otherwise in the past several years due to the overall state of the economy. So that’s what everyone sort of dealing with you thinking right now. Okay. But just looking back on the COVID period when the pandemic began, people already were spending less money. Right. Thats like a recession. You would think that. But you also had a lot of government subsidization, which has led in some ways to great resignation. A lot of kind of unemployment funding was out there. There was a lot of subsidies that were increasing the level of funding those programs are providing. For the first time in history, you had direct deposits into the bank accounts of Americans to actually kind of subsidize lifestyle. And while some of that was meant to stave off economic hardship. Like you look at, for example, I’m doing a lot of work in plastic surgery right now. Plastic surgery businesses saw some of the greatest increases that they’ve seen historically in terms of their revenue, like throughout COVID. Why was that? Because a lot of people got stimulus checks and used that for elective services. I think that now we’re getting to a point where there’s a bit of equal, like a hangover of all of the money that’s sort of been pumped into the economy through that period. And on one hand, I always kind of joke about this with people, but we pumped a lot of money, trillions of dollars into the economy. And then we woke up one day and we’re confused how prices increased and inflation picked up. And that’s like textbook outcome of what you should expect when you’re printing money and putting it into the economy. So that’s sort of how we got here. So I think common sense would have said that there was a slowdown during COVID. That really wasn’t the case because there was so much money being put into people’s pockets. And I think now that economic reality is setting in maybe a year and a half, 18 months later, you’re seeing that slow down happened a bit later.
Praveen Suthrum: Very well explained. So is the government printing more money now?
Abe M’Bodj: They slowed down a little bit, and that’s kind of part of government policy, in terms of the central bank, in terms of looking at raising interest rates, like by default, them raising interest rates is them buying back money that’s essentially in the economy through open market operations and government programs. So they haven’t been printing as much lately, but we obviously did just print quite a bit over the last couple of years.
Praveen Suthrum: Okay. So now moving on to private equity, which is the crux of this interview of this conversation. So you said that the amount of dry powder or the amount of capital to invest has increased substantially in the last few years, almost maybe over a trillion dollars. You said even more. It’s more than a trillion dollars. Yeah. So where is this money coming from?
Abe M’Bodj: It’s typically institutional investors. So pension funds, endowment funds, ultra high net worth individuals, accredited investors like state pension plans, like California state pension plan is one of the largest investors toppers. So very large endowment funds and investors that have tens of hundreds of millions of dollars to put to work at any given time. And I think what’s caused such a great deal of inflow of capital into private equity has been the outsize returns they’ve been able to generate relative to some of some of the alternatives of these groups, which are mutual funds in public markets and in some cases, hedge funds. And so the success that private equity has not just in healthcare, but kind of across the board, has caused those institutional investors to allocate more and more of their portfolios into kind of these private market investments. And so I think, as I mentioned, as I was looking today, I want to say from 2011 to 2021, it’s increased from about $1.1 trillion in active like capital that was available for deployment to about 2.9 trillion. So quite a bit of increase in capital.
Praveen Suthrum: Yeah. So that’s about $1.8 trillion increase in capital. Yeah, that’s a lot of money. So, again, I just want to break that down as well. So the institutional investors, or let’s call them limited partners, as they’re called. These are endowment funds from universities such as University of Michigan or Harvard or wherever. And so they’re giving money, then there are insurance companies, they’re giving money, then there are ultra high net worth individuals. They made a lot of money in the market. So they’ve given money. And so lot of dry powder has been supplied to private equity. Now, this capital is already there. The agreements between the limited partners and the PE companies or firms are already there and they are executed. So they’ve committed to investing that money and giving back returns. So this money has to, so PE has an agenda now to complete the deployment or whatever agenda that they’re in right now. Now, my question, I want to begin with one question from the limited partners point of view. So now that everybody is going to pull back in the current environment, either the generation of market returns will slow down, it possibly will slow down. We don’t know how long, but I’m assuming based on whatever I’m finding out, the slowdown is here for a while, this correction is here for a while. So if that happens, then my understanding would be that they will not supply more money into the market. Is that a correct understanding or No?
Abe M’Bodj: I can see a scenario where, because you’ve got to separate call it the market from what I would call the private market. So you got public market and private market. Public market doing horrible. I saw a stat last month that it was the longest weekly decline of the stock market since the tech bubble had burst in 2000. So decline was greater than 08 or 09. But the weekly extent in the timeline of the decline was actually longer in the last few weeks than it had been in historical slowdowns in the stock market. And so the general stock market is driven by fear, greed, emotion, that’s all part of the investment. And to some extent, the private markets are too. But these investors are thinking about investments over a much longer time horison, right? Five to seven years, call it the average private equity investment. And I think if I’m sitting there as the head of an endowment or a pension fund and we’re entering a world of potential low returns in the public markets, on one hand, you could make the argument that you’re going to see more capital allocated to alternative investment strategies, of which private equity is one of them to find creative ways to get that return out of the market, even though maybe the return, albeit it’s fair, maybe the return could be a bit less over the coming five years than it has been over the last ten to fifteen. But if it’s still exceeding if you think of it like their competition, competition being public markets as we are wondering, you still may see a greater degree of capital allocation into private equity. And we’re actually talking about this as a team. Earlier this week we were curious to see some of the recent fundraising numbers. They haven’t come out yet, but one article I read today was about every year for the last several years has been a record fundraising for private equity. And when is that going to slow down a little bit? And all indications point to kind of continuing. But I think in the backdrop of as an investor, if your alternatives are getting poor, you’re going to allocate more capital private equity. So I can see them continue to raise a fair amount of money.
Praveen Suthrum: So let’s talk about that a little bit more by getting to the level of the PE firm itself. Let’s say somebody who is heading a private equity firm. What would they be thinking right now? Because let’s consider what must be happening to typical portfolio. Let’s set aside health care for the moment. But in general, in the industry, most employers. So layoffs are on the horizon, if not already. And in the tech space, there is a hiring freeze across the board. It seems to be all the big tech firms they hired excessively, assuming the whole world will go digital during the COVID period, which is true from a long term standpoint. But now they have excess people and they don’t know what to do with them. So either there are lay offs, like from Netflix, laid off people. There are other firms that are either laying off or holding back on the hiring. So if they were part of the portfolio and some of them would be so then your portfolio is not hiring much anymore. So there is lesser economic activity in your portfolio companies, which means that the exit that you were expecting within a three to seven or a five to seven year horizon may or may not happen at the level that you’re expecting. You may have a return, you may not find a buyer. I mean, a whole variety of possibilities. What would the PE firm be worried about at the current moment? And then please also add in the angle of lenders and bankers because they have a huge role to play in the investment activity when they’re giving debt.
Abe M’Bodj: You touched on a good point. Like with a lot of companies that have had sell offs or layoffs recently and a lot of the companies that have the largest sell offs in the stock market, there’s been a huge shift in the market. Generally this is across public market and private market. When I say this from really you think of high flying growth stocks, technology, which usually is a big component of that two more value oriented, cash flow driven profitability type business models and the businesses that are susceptible to layoffs at this point are the companies tend to be technology companies that have really over hired, probably weren’t profitable to begin with or had marginal profitability, and so they couldn’t really sustain their workforce and their valuations. A lot of cases were just driven on kind of continued revenue growth. And now that you’re seeing that slow for several companies use Netflix as an example, that is causing these organizations, after rethink their call structures and profiles and causing their investors to rethink it. It’s really the same within the private market as well. There are certain segments of the healthcare economy. I would not put GI in this category because those deals tend to be more profitability driven. But there are segments that were historically trading on revenue multiples or pretty high valuations that have certainly come down because the market is not as favorable to just growth at any cost at this point in time. So I think as you sit at the head of a portfolio and looking at the investments that you’ve made within that portfolio, whether in health care, otherwise, you’re trying to understand what are the cost structures of my investments. How will ultimately the market evaluate these investments upon exit? I think some of these businesses that may have historically been valued upon revenue multiple growth multiple are now trying to think through how they pivot themselves towards profitability. And I would say the urgency to show profitability from investors or outside parties is greater than it has been over perhaps the last couple of years. And so as you think about that, as a portfolio operator, that may include layoffs or redefining the strategy or spinning off and profitable or segments of the business or businesses that maybe haven’t developed in the way that you would have liked. But I think for companies that are still, and this is why healthcare services tends to be a really great area for private equity investment. Businesses that are stable, have stable cash flow, profitable and continuing to grow, can thrive in this sort of environment. Especially as you look at something like a physician practice, which is a bit more resistant to kind of overall price changes. Right. A GI practice is somewhat impacted by inflation, but not really right. Payer rates don’t necessarily change with the price of gas or the consumer price index. So you’re a little resistant to some of those outside changes, which is why it is still a pretty good area to see that you’re continuously investment appetite for those portfolio companies to exit for other buyers is definitely strong. You had a large deal last year with Gastro Health being exited by Audax Group and trading to OMERS, another very large private equity firm. There’s several of these other platforms I’m certain are going to explore exits in the near future. My guest, GI alliance, will likely see a secondary transaction in the next year or so, as well as some of the others are going to start to explore it. So again, just circling back, if you’re in that position or you have a strong company with strong cash flows, you don’t have to change how you’re thinking about the investment a whole lot as it relates to health care. If you’re in an area of health care where it’s more of a growth oriented play and you’re thinking about how do you exit into the current market, then you’ve got to think a little bit more about what that strategy looks like in your time horizon, because I think it is changing a lot for a lot of people.
Praveen Suthrum: What are the bankers thinking?
Abe M’Bodj: Well, I guess to back up. So from a lender perspective, rates are increasing. So that impacts things in a couple of ways. One, from a banker standpoint, you know that if we tend to work on the sell side, so working with the organizations that are bringing on private equity capital or seeking to be acquired or some type of investment partner. So you know that with rates increase historically and potentially can’t have an impact on valuations. Right. And so as a private equity firm is going through their model and building that out and they’re making their assumptions on their entry investment and what the cost of that capital is going to be from a financing standpoint, the plug in that model, that is the interest rate on their debt gets a bit more expensive. And so as that filters through and ultimately will come back that they can definitely pay a little bit less for their investment. Again, though, going back to the comment around how much capital has been raised. We’ve seen such competition for these as a banker, which is a good thing for us. We’ve seen such competition for our clients in these transaction processes from various private equity firms as well as larger health care strategic organizations that we haven’t seen that impact of that financing actually impact valuations really at all or as much as expected. In fact, we’re pretty consistently exceeding kind of valuation expectations that we set at the outset of the process through the transaction process. So we haven’t seen that yet. It’s definitely a possibility. I will say groups are definitely and this is getting back to lenders. Whereas during COVID there were a lot of businesses that were impacted negatively throughout the course of COVID, whether that was and Phil have in some cases like trouble staffing, like it’s a staffing type of organization, staffing caregivers and providers, and in some instances, nurses in a lot of instances has become more challenging. So that was definitely a struggle for some of those organizations. You were able to make adjustments to the finance or really any business that saw like a downturn as a result of COVID. We were able to explain a lot of that stuff away with investors and lenders and be honest truth that some of that has come back and some of it hasn’t. So there are certain things that people had bought off on that didn’t come to fruition, both lenders and investors. Again, as a banker, our job is to ensure that, ensure we get our clients credit for those things. But the reality is some of those adjustments that people make to EBITDA or revenue or whatever it may be have come to fruition. Some of them haven’t. And the key thing that you focus on in the process is like showing a trend back to normalization. I think that now in the current environment, people are there’s not as much appetite for those types of adjustments. So whereas maybe twelve to eighteen months ago you could get away with some of those things, right now you really can’t. And so people are pretty heavily diligent saying those types of adjustments to the quality range. So I guess to answer a question from a lender perspective, it’s definitely getting a bit more stringent in terms of underwriting requirements.
Praveen Suthrum: If Gastro Health were to exit now or in the coming months, and let’s say we’re in peak recession, would they get the same valuation that they got? First of all, would they find the buyer? And second of all, would they get a similar multiple as they did last year?
Abe M’Bodj: This current environment wouldn’t impact their ability to exit if it was six months later. I don’t think it’s going to be the case for some of these large organizations that are exploring exits. The reason being, again, it’s a fast growing but profitable organization and they’ve kind of established themselves within the market. So there’s very strong economic fundamentals behind those investments. That’s different than a technology investment that could grow a lot and has shown and demonstrated the opportunity to grow quite a bit. But I think they’re in kind of a different category where there still would be a fair amount of appetite. You’re seeing a kind of across physician practice management. There’s been several pretty high profile exits over the last call it six months, not just in GI, but in other specialties. I think you’re still seeing that appetite. And then even I can say there’s still a lot of appetite for private equity firms to find platforms within various areas of physician practice. And we can talk specifically about where GI is at. I think it’s tougher to find a platform investment outside of one of the larger groups that’s already been created as the platform, as a second bite of the Apple. But I’m doing a lot of work in the Cardiology space right now and there’s insane valuations are being paid for these organizations because of the market opportunity exists irrespective of the kind of outside market. Even higher than they were at the peak of some of the GI activities. So you definitely have a lot of appetite from investors to find assets in these spaces. But to your question, I don’t think would impact. Let’s say Gastro health was transacting right now, I don’t think they would be being impacted in their transaction.
Praveen Suthrum: So you’re saying even the valuation would be the same?
Abe M’Bodj: Valuation would be the same, yes.
Praveen Suthrum: Okay, so now talking about second bites of some of the other platforms that got their start in 2018 and after. So one would expect just adding five years to that, so one would expect that they would be exiting next year. So we would see second bites next year, which means that the groundwork for that should have begun already. That would be my take. What’s your take? Is that going to change or based on what you just said? I’m assuming you’d say that no, they’ll find the exit and they’ll find at the valuation that they would normally find.
Abe M’Bodj: The groundwork has definitely been laid. I suspect with a pretty high degree of confidence. Some of them are exploring exits at the current time. However, I think it’s fair to say there’s been varying degrees of success amongst the platforms that have been created in the market. And so the ones that I would place on the spectrum of more successful relative to others, like they’re in good position to exit. The ones that I would place on the farther end of the spectrum in terms of having a successful transaction, they’re probably going to have to hold on to the assets quite a bit longer. My actual suspicion is that you’ll start to see those organizations get acquired by the ones that do have successful exits with their next partner. But the challenge right now in the GI space, I don’t want to say it’s a challenge, but these platforms, namely like Gastro Health and GI alliance and One GI has had so much success in such a short amount of time and in partnering with so many groups. I’ve seen a report the other day that 10% of the 14,000 gastroenterologists in the country are part of these private equity backed organizations. But these groups have had such success that there’s really not entryway for a new platform to come into the space. So you’re pretty set. Like if a new GI group wanted to go and find a platform investment, it would be pretty hard. Look at the current state of the market, but what you do have is this kind of captive pool of investors or buyers that now have intense competition for assets or groups that come available in the market and even for relatively smaller transaction opportunities. So not impossible for sub 10 doctor group to be trading at a double digit multiple because there’s such intense competition to partner with those groups for these larger groups to have a successful outcome within their transactions. But I think that the groups that are I don’t have to say who they are. People know who the more successful groups are. People know who the less successful groups are. I think those groups will have an easy time exiting and the other groups will probably spend a bit more time in the market finding their way. Ultimately, I suspect a lot of the slower growing groups will probably be acquired by some of the other larger ones. And that’s like not unprecedented across physician practice management. For example, one of the largest OBGYN providers is a company called Unified Women’s Healthcare. Unified Women’s Healthcare was a portfolio company of Ares Management wasn’t his from 2013 until very late in 2020. And they did a recapitalization with another private equity firm called Atlas Partners. With Atlas Partners, they actually went and bought the second or third largest OBGYN platform company called Women’s Health USA and brought them into their organization. So it’s not unprecedented for you to start to see some of these larger platforms combined and grow with one another.
Praveen Suthrum: Yeah, very interesting. So now if you look over the shoulders of some other specialties that are ahead in the PE game, how has it played out once these large platforms started acquiring more and started exiting, there’s been a second bite or maybe even a third bite and some. So when those transactions have happened, have they gone multi specialty, have they gone across the board or what is the norm or is there so much room for growth even within specialties that are the transactions just making these companies larger and larger within a single specialty? What have you observed?
Abe M’Bodj: It varies a bit by specialty. I would say for most of the specialties over the course of the last ten years, they’ve all gone through 2nd, 3rd transactions and it’s all been still kind of single specialty with a couple of exceptions. But where sort of the area the playbook came from for multi site investment in position practice was really the model of dental practice management. And many of the dental spaces is so fragmented and there’s so much room for growth that even the largest dental organizations out there in the market, their number one way of still growing today is by partnering with solar practices and solar practitioners. That is different than what you’ll find in the GI market. It’s very fragmented, but it’s not as fragmented as called densely. So I don’t think it would go on forever like it is in dental. Now, what you saw with some of the outsourced, maybe hospital based service type physician practice management businesses, those grew and I’m talking like anesthesia radiology emergency medicine. Those did ultimately end up combining. And you had the creation of the Envision Healthcare, which I know ultimately had some trouble as well as Team Healthcare. But those ultimately became, I think when Team was taken private, it was $18 billion transaction. When Envision was taken private, it was about eleven or $10 billion transactions. So those became extremely large organizations. And then as you think about the Ophthalmology and just going along the timeline here, like pain management, ophthalmology dermatology, most of those businesses have gone to their second bite of the Apple. None of them have started to change specialties quite a bit. All that I would say on the Ophthalmology side, you start to see some of those kind of blend on the more optical side, which is kind of interesting. So continuing to get into the consumer angle on that piece and you’ve continued to see that grow. And then on the women’s health side, interestingly circling back to the Unified example I gave. That’s an example where you’re starting to see a crossing of specialties in a way. So like Unified, shortly after they had bought Women’s Health USA, they also acquired CCRM, which was one of the largest fertility, private equity backed organizations. I think it was 500 or $700 million transaction. So it’s fairly large. And so that’s an example of them. You could view fertility as like an ancillary service of women and women’s health relative to pure OBGYN services, but that’s an example of them kind of crossing into a different specialty. So I don’t know where it ends with GI, just going back to GI, I don’t know where it ends specifically. There’s been some talk of integration amongst Urology platforms and moving into other areas. But I don’t think that within GI you’ll start to see mixing and specialties just yet.
Praveen Suthrum: Where is GI right now in terms of you said 10% of the gastroenterologist are under A private equity platform if you break the whole market down. I remember having this conversation with you several months ago now, but if you think of it as a pyramid at that time, I remember you saying that most of the big groups are gone. There are some still so are they exploring transactions? Have they decided not to do it? What about the middle and what about the huge base of this pyramid that all the different smaller practices have they decided? I mean, those who decided to do a transaction have done. Are people still in the middle or have they decided, hey, this is not for me.
Abe M’Bodj: I maybe over generalizing, but generally, if you’re over generalizing, but generally, if you’re a large group, call it north of 15 doctors, even north of ten, you have the opportunity to transact. Whether it was a banker called you, a private equity firm called you directly or one of the platforms in the market, you likely tried to at least figure out and get educated on whether or not a deal could make sense for your group. And I think the groups that are still independent, like have decided that it’s just not the direction they want to go. That’s completely fine. And those groups will still have the opportunity to transact. I think the challenge some of those groups may have is that the impetus to transact for some of these practices can’t be like that. They want an exit strategy for the senior partnership or the leaders within that group, because then it won’t set them up for a great transaction when they ultimately go through it. I think if these groups change their minds and want to explore transactions, it really needs to be based on some sort of change in thinking that it makes sense to become part of a large organization and join and grow. From an equity standpoint, that’s what I would call the top end of the market, top to middle. I would say that the base of the pyramid for them, the market is actually in a really exciting time because these are the groups that didn’t have a lot of options before. There was this ecosystem of private equity firms that created called sub five doctor practices, right, where there aren’t private equity firms calling them to invest in them as a platform for those shareholders. They’ve now had the opportunity to create liquidity from the practices that didn’t exist for them for the last five years while all these other large practices were doing deals. And so I think it’s an exciting time in the market from that standpoint because that is obviously creating  a lot of opportunity for those gastroenterologists, and it’s also creating a lot of opportunity for the private equity platforms that are invested in the space. Right. Because that’s where they actually create your return. You don’t create your return by going and buying 15-20 largest groups in the country create your return with what you can do after that and because you can expand within all of those markets by partnering with smaller groups. So I think the base / lower middle of that pyramid is where you’re seeing the most activity at the moment.
Praveen Suthrum: Earlier, in the conversation Abe you talked about during the pandemic transactions happened, people, the investors gave transactions a little bit slack. And you said some worked out and some did not. It did not play out as they thought it would. I think we’re talking about deferred income and the growth activity will pick up. And you said for some it did not happen. I want to talk about that for a moment. So what happens in that case? What are the risks that we are dealing with? I know you’re an investment banker, and you would say like, hey, everything is great, but I just want you to step away from that for a moment and help me understand what are the risks that we are dealing with. Risks from the PE standpoint, risks from the portfolio standpoint, from the platform standpoint, from the people who have joined the platform standpoint. And ultimately, if you’re a small practice or medium practice, that’s right in the middle, what are the risks that we are dealing with? What would go wrong?
Abe M’Bodj: The risk ultimately is that the earnings or the EBITDA that you’re basing the transaction on, right. If the deal is based on an adjusted EBITDA, just pick a number of 2 million and you as a buyer paid ten times multiple on that for 20 million. And then you fast forward there were adjustments in there maybe for code, productivity or positions were out or whatever it might have been. And fast forward at twelve months after the deal, if EBITDA is 1.5 instead of 2, what did you buy? Right. You bought something that was worth 15 for 20. That’s the ultimate risk. And then the downstream impact of that is obviously it has a negative impact on the equity value of everyone associated with the organization. What I would say is that’s actually within GI specifically and really most physician practices, that hasn’t been the case. There has been pretty strong normalization of trends post COVID. That comment I had made was somewhat related to what we’ve seen in some of the post acute space like home care providers and home help providers, where some of these businesses have had trouble staffing kind of providers and nurses into care settings. And that market has been a bit more challenging and has not come back in the same way that some of the other areas of health care have. But within the physician space, you can look at the financials and most physician practices and they’re over and above what they were pre COVID. But going back to that, the risk is that there are likely some deals that happened during COVID or shortly after where the earnings didn’t materialize. I think we actually talked about this quite a bit in our last discussion, though. The investors in the private equity firms, they did do a pretty good job of protecting themselves against that profitability or that earnings not coming back. So that’s what everyone was dealing with at that point in time. Like, how do we structure this deal in a manner that gets the practice full value? Go back to our $20 million example, you may get your 20 million. It may take ten upfront five and five over the next two years while we see volumes come back. Those types of structures are gone, nor do sellers want to accept them. But I think it’s also shifted towards just being more thoughtful around adjustments that could be made to the financials. But to answer your question, the downstream impact of that is impacting the equity valuation. If it’s a platform, obviously that could potentially get you into issues with your lenders, which could put you on the path towards bankruptcy. I don’t think anyone’s had that issue at this point. That’s a potential risk. So everyone’s being very thoughtful on that.
Praveen Suthrum: Are we going to see any announcements in Gastroenterology in the coming months, new platforms, any major announcements that you know.
Abe M’Bodj: I don’t think of any new platforms that are being created. I know we knock on wood should be announcing a deal the next couple of months with a group that’s partnering with an existing platform. So there continues to be groups that are doing transactions. If I had a Crystal ball, I don’t know anything for certain, but I would expect by the end of the year you’ll probably see another one of these very large one of the staffers platforms exit to a larger investor.
Praveen Suthrum: On that note, a fantastic insight into what’s happening in the PE world and specific to GI very insightful. I learned a lot from this conversation and thank you for being so open and candid and clear about everything. I always appreciate that once again I thoroughly end up enjoying and learning a lot every time I chat with you. So thank you thank you for coming today and sharing your perspective.
Abe M’Bodj: Thank you very much Praveen for having me. I always enjoy speaking with you and I always enjoy hearing your perspective on these things as well. You have a unique one and I always enjoy whether you’re doing these types of activities podcasts and getting this education to the stakeholders in these industries because I think it’s important and you do a good job of it, but thank you for having me.

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COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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09 Jun 2022

“More data, better diagnosis” – Founder & CEO of FoodMarble (Interview)

“More data, better diagnosis” – Interview with Founder & CEO of FoodMarble, Aonghus Shortt
We are back with the next season of Scope Forward Show where you’ll get to meet innovators and leaders who are reimagining the healthcare system.
The next phase of GI depends on innovators such as Aonghus and FoodMarble. Why? Because the industry is shifting from under our feet. Four trends are influencing GI: exponential technologies, consolidation, big brothers (such as hospitals, insurances) and changes in patient behavior.
FoodMarble, a tiny device that analyzes digestive disorders such as IBS and SIBO, comes squarely in the middle of these trends. After selling 30,000 devices, what do they know about patients with IBS that a private practice does not? How can this be a new revenue-generating ancillary opportunity?
The story of its growth is also interesting. An engineer gets an idea after seeing his girl friend suffer. Ideates and develops the device in Ireland and China. Raises $6 million and sells globally – more than 2/3rd in the US. It’s indicative of how the next phase of innovation would happen.
Aonghus says, with “more data”, you can come up with a “better diagnosis”. True.
Welcome to the evolving world of data-driven GI.
Don’t miss this one.
How does an engineer/PhD enter GI?
FoodMarble’s journey from Dublin to China to US
Why is Hydrogen used as a primary gas for digestive breath testing?
The secret of listening to breath signals
Demo of the second generation medical device med AIRE 2
“We’ve sold over 30,000 devices so far”
“It can provide a considerable source of revenue for clinicians”
Correlation between stress and digestion? Can the device sense it?
Short term and long term growth plans for FoodMarble
“If you capture more data, you should be able to do a better diagnosis.”
◘  Will FoodMarble consider branching off to diagnose other conditions?
Fundraising?
“Right now there’s not much for patients suffering from functional GI disorders”
Vision for the future of GI


The Transcribed Interview:
Praveen Suthrum: Aonghus you’re the CEO and founder of FoodMarble which is a breath analyzing device that I’m excited to learn about. I warmly welcome you to The Scope Forward Show.
Aonghus Shortt: Thanks very much, Praveen. I’ve always loved Scope Forward Show. Just really informative and just delighted to be invited.
Praveen Suthrum: Aonghus, you are a PhD in engineering in a completely different field, and you’re a data scientist. How does somebody with your background get into a field like gastroenterology?
Aonghus Shortt: It’s a good question. It was actually my wife while my girlfriend at the time. She has IBS, and she was struggling. She was having a really difficult time. She’d been to different types of clinicians between primary care, she’d been to a number of gastroenterologists. She tried enough medications. She, of course, had a number of procedures, and she didn’t find anything they were very worried about. So kind of a really common story where people end up with a diagnosis of IBS. And I just started doing some research to see because I had access to the literature. So at that time, breath analysis had been used for quite some time because of large benchtop devices. But I could see the low FODMAP diet was emerging from the literature. And this was kind of an approach where if you can identify which foods ferment rapidly into gases in the gut and reduced down the consumption of those foods, that you could feel a lot better. And it was remarkable for me because I could see that in those early trials of Low FODMAP diet and as many as three or four people were seeing significant improvement, people at least tend to feel better. So they were using breath analysis in that research. So it kind of triggered me to think, okay, can I build one of these devices for Grace? And when she’d eat it, she’d see sometimes very significant rises in the breath hydrogen be measured. That was quite a good signal in terms of maybe this food should limit in her diet. It’s a pretty cool way if she was able to start personalizing what she could and condition. I guess that was sort of the inspiration for what we’re doing today.
Praveen Suthrum: That’s an amazing backstory. So how did you get started?
Aonghus Shortt: I started working on the original prototypes back in 2014. The accelerator program is at the start of 2016. We spent a couple of years developing the device and just getting it up to a level where it was performing really well because it is really challenging to measure these breath gases at the concentration levels. We need to measure them out on the breath. Yeah, there was a lot of product development that went in and just even learning from users using the device, giving feedback, letting us know and kind of us being able to build up that app guided process as well with their users. That took a while, but it’s really beneficial for us I think.
Praveen Suthrum: From my understanding, why did you choose to focus on hydrogen as a gas, like for the lay man, if you can explain why hydrogen in particular?
Aonghus Shortt: Yeah. There’s a few gases that are relevant on the breath. And so hydrogen is probably the primary gas. So whenever if you eat something, essentially, it’s not absorbed or it’s not fully digested, and it gets as far as microbes that can break it down in the gut. So that might be the small intestine, but usually the large intestine. If you get that undigested food to that point, it starts to be fermented by the bacteria or the different microbes in the gut, and that’s producing hydrogen, carbon dioxide And lots of other different metabolites. Hydrogen is the kind of primary gas that’s produced. Some of the hydrogen can be turned into methane, which is another gas that’s often present on the breath. Some of it can be turned into hydrogen sulfide as well. There is a couple of other gasses on there. For a first generation device, we want you to measure hydrogen because, first of all, it is the main gas of interest. But then also, when it comes to people being able to identify what foods they can and can’t eat, hydrogen is very responsive to the food that people are eating. If you’re not digesting the food effectively, you’ll often see very significant increases in hydrogen levels. And if you’re not seeing it, that’s a good indicator that this food might be actually okay for the person. So that was the first one. But in our second generation device, we are measuring methane, and we should be able to release an update on that device where we’re also measuring hydrogen sulfide on the breath. So in our sensing array, we have the capability to measure all three gasses in our second-generation device.
Praveen Suthrum: What is in the device that listens to the signal of hydrogen? How exactly does it sense?
Aonghus Shortt: Inside the device there’s a sensing canal. So the person is exhaling into the device, and there’s a sensing array inside of there. So multiple sensors which are measuring effectively. There’s a signal that’s generated by the sensors. It’s measuring the electrical resistance of process sensors. So whenever the molecule of interest comes in contact with the sensor, it kind of temporarily attaches to the sensor, and then it kind of detaches it again. So you’re having all of these reactions happening on the surface of the sensors while they’re exposed to the sensors.  So we get a signal. Then, in effect, we’re getting multiple signals that are coming from the sensing array. And then there’s all sorts of different kinds of models we’re using to be able to translate that into concentration levels that we can show to the clinician and show to the patient.
Praveen Suthrum: Aonghus I’d love to see the device if you have it with you. I’d love to see how it looks. And if you can show it to us.
Aonghus Shortt: Yeah, sure. So I’ve actually got this is actually the second generation medical device which is coming up. This is med AIRE 2. So if you can see here. So this is a mouse piece at the front which you can click off, and you can wash the on and off button at the top. And so you can see the canal here. So you’re breathing in here and the breath comes out the other end and you can see as well. There’s a USB Port on the side.  So that’s for charging the battery.
Praveen Suthrum: And it communicates via Bluetooth?
Aonghus Shortt: Yeah, exactly. So it communicates with the phone over Bluetooth and then the readings can be uploaded to our cloud servers. So then the clinician is able to see the results through the dashboard at that point.
Praveen Suthrum: Sounds so fascinating. Now can you share some numbers? How far have you come?
Aonghus Shortt: Yeah. So we’ve sold over 30,000 devices so far, so most of those are direct to consumers. So initially we started offering the device direct to consumer at the end of 2018 through our website. More recently, in the middle of last year, we started selling a medical so our first medical device, it’s an FDA class one device which we call Med AIRE. So that’s now available in the US. In terms of other numbers, we’re 25 people based over in Dublin, but we’re often in the US, we’ve raised over $6 million of VC funding. And yeah, we’ve seen a steady growth. So last year, we saw our sales double compared to the previous year. And again this year, we’re seeing really good growth as well. So there’s certainly a lot of interest from consumers and also from clinicians. And often what happens is a consumer buys a device, they’re gathering data, and they come into their gastroenterologist. And probably many of the people on the show might have had this experience. I guess about a year ago or so we decided, okay, we need to be able to build a system where we can provide a dashboard to the clinicians to see the results. And also we’re making it possible by having a medical device. The clinician can use that. And from a kind of considerable revenue point of view, it’s something that they can add to their practice and it can be a source of revenue as well.
Praveen Suthrum: Can you talk a little bit more about that? How could a clinician earn money by partnering with you? And how could it be a source of revenue for them?
Aonghus Shortt: Yeah. So basically the way we do it is that if a clinician gets set up with us, it’s been possible for them to order devices that get sent to their patients. So we can send them directly or we can send them a bulk number of units that they can have to hand because sometimes the clinician wants to be able to give the device directly to the patient if they’re coming into their office. In this instance, then the clinician is also able to avail reimbursement. So there’s reimbursement for the breath test. For breath tests that have been done traditionally. So it’s the same reimbursement codes. And something we’re also doing more and more is where the device has been used from a remote physiologic monitoring perspective. So that’s an RPM idea is something that’s getting increasingly because these are conditions like IBS, SIBO, functional constipation. These are conditions where it really makes sense to track the patient over a period of time. So clinically, if you’re measuring, for example, for functional constipation, measuring methane levels in the brain is very relevant because constipation tends to correlate with methane levels in a lot of patients. But yes, there’s different models that can be applied, and it really depends on what the clinician wants to do. But fundamentally, there’s a dashboard for the clinician to be able to review the results from the patient, and so we can guide the actual patient through the procedure of doing breath tests. So that could be SIBO breath tests or tests for different food intolerances or as I said, remote monitoring.  So we keep it really easy for the clinician and for staff to be able to set up patients and to be able to interact with the patient. It just makes it a lot easier for a clinician to be able to do breath testing and facilitate that from the home.
Praveen Suthrum: Does this come under the same category as other remote patient monitoring devices, such as blood pressure cuff or you measure diabetes and you send that to the clinician, would it come under the same category?
Aonghus Shortt: Yeah, exactly.  So from a Reimbursement perspective, it’s the exact same code.
Praveen Suthrum: Yes from a Reimbursement standpoint?
Aonghus Shortt: Yeah. Also, it’s a very similar concept as well. So you’re tracking data that’s relevant to the course of treatment. For example, if a patient so initially they might be diagnosed, the GI might diagnose them with SIBO. So if they did conventional SIBO breath test, which is a kind of a fasting morning breath test, and that can be done remotely using our device if they determined that, okay, this patient appears to have SIBO, and in most cases, they proceed to treating with vaxamin, which is an antibiotic, like during the course of treatment and after treatment, you’re able to monitor the levels of hydrogen and methane in the patient. And that’s really relevant because, well, first of all, you want to see, did the treatment work and is in the course required. But then also after the patient has been treated successfully, in about half the cases, SIBO tends to return. So for some clinicians, they might be interested in being able to monitor the patient to see, do the symptoms return, do they need to do another course of treatment, or what’s the best next approach for this patient, because for a lot of these conditions, you need to try different things. So you might like in SIBO, for example, you want to identify what is the underlying cause and what can bring the patient to a resolution, because you might be testing placebo and you clear it with antibiotics. If you don’t identify and resolve under lik cause, they may still continue to have symptoms. So, for example, you might have where a patient has very slow motility, so the food is passing very slowly through the gut, and sometimes maybe using a pro kinetic agent or something like that might be beneficial. But if you’re able to track their fermentation levels in real time over a period of time, that could be really beneficial in terms of treatment.
Praveen Suthrum: I’m really curious about that. So do you write into the EHR? I’m getting into a little bit of detail now, but how does the clinician I think what I’m trying to figure out are two things. One is from your end, one is from a clinicians end. If you’re providing a dashboard, or if you’re writing, let’s say into the EHR, whatever, how can I get a longitudinal view of a patient’s condition? One. Second is how can I get a population view if 30,000 people have used the device? What have you learned from it? These are two questions mixed into one.
Aonghus Shortt: They’re both really good questions. So, first of all, from the perspective of how does the clinician monitor results? So in the dashboard, they can see charts of the patient’s data over time, so they could be looking at their breath readings, they could be looking at their intake of fermentable carbohydrates. So what the patient is eating, they could be looking at their symptom levels. Fuel tracking can be very relevant, especially if you’re talking about functional constipation or IBS. So they can see that data over time and they can look at it just at a specific day, or they can look at over a week or a month or over a longer period of time. And we also try and make it possible.  You can also see the trend in the data. So we try and make it easy for the GI to see whether the levels tend to be going down or maybe they’ve started to go up again. So there are some of the key things that they’re looking for. But it’s something we’re building on all the time. So you mentioned the population level data. So something we want to get into the dashboard is where the gastroenterologist is able to compare the results of this patient against the broader population or different kind of cohorts of patients. So that’s something we’re looking into, because what we found, which is kind of remarkable, is different individuals are in terms of their breath readings. When we’ve done clinical trials or what we’ve been involved in different studies, it’s just a huge range in terms of people’s daily patterns and their longer term patterns. So some people their levels go up and down quite often during the day. Some people it’s a slower progression, and a lot of that seems to link to how quickly or slowly people digest food.
Praveen Suthrum: Is there a role of stress here? I’m just curious. So do you see a correlation? If people are more stressed? Does the condition flare up and do you sense it in your device?
Aonghus Shortt: We do invite the patients and the users to be able to record their stress levels. Certainly stress is a factor in digestion. It’s something that there’s probably a two way correlation there. Your other symptoms can provoke stress and then where stress can provoke your symptoms. We’ve definitely seen a certain amount of that in the data and to provide assistance to people as well, to be able to try and manage that side of things. And in the future, we’re hoping to partner with other app based technologies, for example, which can help from that perspective as well.
Praveen Suthrum: Now you have the benefit of more than one clinical study, isn’t that right?
Aonghus Shortt: Yeah. So we’ve done a number of studies validating the device itself and then more recently, looking at interesting ways of using the data.
Praveen Suthrum: So coming back to the business aspect of it, are you in touch with insurance companies? What are they saying? The US?
Aonghus Shortt: Yeah. From a business point of view, this is something that we want to develop because we haven’t had any discussions so far with payers. But this is an area where you’ve got like, IBS is the number one diagnosis in gastroenterology. You’re looking at different cohorts of patients, like, say, for example, IBSC, which is IBS that’s constipation predominant. I was looking at numbers just before the call where the average was an extra $4,000 per patient per year, which isn’t as much as some other conditions. When you’re looking at the amount of people that are affected, it becomes a very big number. It is a huge cost for payers. And we think of the different drugs that are used. They can be expensive. And so I suppose from a payer perspective, we can offer a tool that you can save a lot of money. And because value based care is coming, and we think we’re very consistent with that as well.
Praveen Suthrum: So you’ve raised $6 million, you’ve sold 30,000 devices, and two thirds of that is in the US. What happens next, short term and long term? What are your growth plans?
Aonghus Shortt: Yeah. So there’s some really interesting things that we’re looking at with some of our research collaborators. We’re doing a clinical trial at the moment, for example, over in Johns Hopkins, and it’s looking at  where you’re using breath readings instead of kind of looking purely at a single snapshot, fast eating morning breath test, if you’re gathering data over a period of time from the home as a patient. So if you’re recording your meals, you’re taking breath tests just during the day. So if you’re taking breath tests after you eat, well, first of all, that’s quite convenient for the person because they’re measuring in the home in a sort of more conventional sort of way. You’re getting to capture how does somebody actually respond to food when it comes to actual diagnosis and guiding the course of treatment becomes especially interesting because what we found in our trial is that we were looking in particular at seeing if somebody would respond well to rifaxman, which is a drug that’s approved for IBSD. We found that this approach seemed to be much more effective than the conventional test. So instead of replacing kind of single snapshot testing with where you’re gathering data over a period of time seems to be very powerful, mainly because the digestive tractors antidepressant trial disk knows there’s a lot of variability. There are a lot of factors that affect your digestion. So if you’re able to capture more data, you should be able to do a better diagnosis.
Praveen Suthrum: Do you see yourself branching off into other disease conditions, or would you stick with IBS and similar conditions?
Aonghus Shortt: Primarily, we’re very much focused on disorders of the gut, and we think that you’re seeing increase in evidence that where the microbiome and the gut is affecting broader health as well. So we will be very focused around the GI tract. That’s a pretty broad scope. So IBS is certainly very important to us. SIBO, functional constipation. These are some of the key kind of target areas. But we do think that what we’re doing could be relevant in other areas as well. So we’re doing a study actually in IBD patients, which is very interesting, and we will probably do more in respect of IBD. But yeah, so there’s a lot more we can do because fundamentally when you’re looking at breath, it’s something that can be gathered very easily. You can gather it over time longitudinally. The actual equipment for doing it is accessible from a cost point of view. So we think there’s a lot of potential. And say, for example, with the trial at Johns Hopkins, we’re applying machine learning to the data, and then it becomes even more exciting. So, yeah, I think that there’s a broad range of things that we can do. But yeah, our focus right now is really on somebody’s kind of really common but hard to manage GI disorders.
Praveen Suthrum: Are you raising more money? What happens from a fundraising standpoint?
Aonghus Shortt: Yes, we’re doing around at the moment. And so you’re very interested to speak to anyone who’s investing at the early stage, really with a focus on US investors as well, because from a healthcare perspective, our complete focus is on the US. And, yeah, we’d love to hear from anyone who might be interested.
Praveen Suthrum: Excellent. Is there anything else that you want to share before we close?
Aonghus Shortt: I think for us we do see a big gap where there’s a lot of people who have some of these functional gastrointestinal disorders. Right now, there’s not that much for those patients. We just want to sit in that gap and to be able to provide something that’s really convenient for the gastroenterologist and their staff and something from a practical perspective can be a revenue generator also taking breath and these measurements combining with machine learning for example, there’s just so much that can be done with that. Looking forward we just want to keep expanding what’s possible using the technology.
Praveen Suthrum: Is there a vision that you have for the future of GI? Everything happens like you think it should? What does that look like? What does such a future look like?
Aonghus Shortt: The way it should be for patients who are coming in and it could be something like half of patients coming into gastroenterology but have conditions that would be relevant to what we’re doing. So for those patients coming in if we can give them the technology where they can go home, gather data over a period of time and use that to manage treatment. For example, if they were to take over the counter supplements like identifying which are helping them if they were to take different medications help the clinician choose which would be most beneficial. It could be just purely food related so deciding whether this patient is a good candidate for example a low FODMAP diet or maybe another type of diet that might be more suitable for the patient. If you’re able to guide the patient over a period of time through that process remotely it’s something that will cost a lot less money it’s something that will be much more effective for the patient and for the clinician as well. Just the satisfaction of being able to treat the patient really effectively because these are really hard to manage patients because they’re really complex conditions.
Praveen Suthrum: Aonghus Shortt thank you so much for joining us today on The Scope Forward Show. I’m excited about what you’re building. Always admire and respect innovators. What you’re doing is fantastic. I wish you great success, you and your team.
Aonghus Shortt: Thank you once again, thanks Praveen.

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COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
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