Category: Videos

13 Jan 2023

Sam Jactel, CEO of Ayble Health: “Being patient centered is different than being patient driven”

Sam Jactel, CEO of Ayble Health:
“Being patient centered is different than being patient driven”
At the end of the interview, Sam Jactel, GI patient turned CEO talks about Thomas Nagel the philosopher. In a paper from 1974, Nagel famously asked us to contemplate “What is it like to be a bat?” He suggested that you may be able to study the behavior of a bat but you can never really know what it’s like to be one.
Sam takes that analogy to his own GI condition. He was tired of looking for answers within the industry. He was tired of not being seen or heard. And he ended up figuring out a solution that worked for him. Then he thought why not help other patients like him. That prompted him to go from being the CEO of his own condition to becoming the founder and CEO of Ayble Health. This digital GI startup has raised $4.6 million from investors.
Watch this incredible interview. It’s a sign of the times. Expect more patients to become digital healthcare providers because the industry isn’t stepping up enough.
◘  From being a patient to becoming a CEO: The story behind starting up Ayble Health
◘  What is really missing in the GI industry?
◘  “The needs of the patients are either filtered or not heard”
◘  “The challenge that I have with GI and healthcare, in general, is that…”
◘  “Being patient-centered is different than being patient-driven”
◘  “With the tools that we have at our disposal, we are not driving optimal outcomes for patients like myself”
◘  “There aren’t even enough GIs to meet demand”
◘  Ayble Health raised $4.6 million. What triggered investor interest?
◘   The business model
◘  “We are part of the UCSF Rosenman Institute ADAPT program”
◘  The startup’s payment model
◘  Is the use of AI and machine learning really necessary?
◘  Is there a need for more and more digital GI companies?
◘  “We want patients to be seen”
◘  The future of GI & healthcare
◘  “I think that there’s too big of a gap currently between the claims that companies make in digital health and the evidence that supports it”

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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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22 Dec 2022

“Physicians are at the epicenter of changing the way we live our lives” – AGA launches GI Opportunity Fund

“Physicians are at the epicenter of changing the way we live our lives”
AGA launches GI Opportunity Fund
Scope Forward has always been about finding the way forward for gastroenterology. Naturally I was excited that a leading GI society such as the American Gastroenterological Association (AGA) was scoping forward  by launching a venture capital fund called the GI Opportunity Fund (in partnership with Varia Ventures).
What was even more exciting is that AGA chose to invest in Virgo to launch the fund. I interviewed Virgo’s cofounder Matt Schwartz earlier this year – we talked about the value of data in GI.
In this interview, you’ll learn from Tom Serena (CEO of AGA) on why (and  how) AGA chose to go down the route of venture investing. How the market opportunity for GI is enormous. How to invest and participate in this fund? If you are an entrepreneur, how to land an investment.
More importantly, you’ll understand the central premise of this interview. As Andrea Vossler, Cofounder and Managing Director of Varia Ventures said, physicians are the epicenter of medical care. You are the ones who are innovating. It’s time to step forward and make your ideas into a reality. If you listen closely, Matt has this one piece of advice for GI entrepreneurs.
◘  Why is AGA getting into venture investing
◘  “We have been staying sharply focused on GI”
◘  “The market opportunity for GI is enormous”
◘  What kind of GI or health tech companies will Varia invest in?
◘  How will the GI Opportunity Fund help Virgo?
◘  What benefits does Virgo offer to the GI community?
◘  What kind of exit horizon do these investments have?
◘  “Our goal is to get Virgo integrated into as many health systems around the globe as quickly as possible”
◘  “Pivoting,” within a large organization such as the AGA
◘  How will the GI Opportunity Fund evolve in the coming years?
◘  “We’re all looking at private equity and how that’s going to affect not just GI but us”
◘  “Physicians are right in the epicenter of changing the way that we live our lives” 
◘  What is the process of becoming an investor in the fund?
◘  What is the typical size of the investments that the fund makes?
◘  The number one piece of advice to entrepreneurs in the GI space
◘  What is the future of GI? 

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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.
button_download
11 Nov 2022

Dr. Jonathan Ng, CEO of Iterative Health: “Not using computer vision is a barrier to health equity. But will it replace GIs?”

Dr. Jonathan Ng, CEO of Iterative Health:
“Not using computer vision is a barrier to health equity. But will it replace GIs?”
I asked Jonathan Ng, founder and CEO of Iterative Health (formerly known as Iterative Scopes, an AI in GI startup) why investors recently gave them $150 million in funding. We didn’t exactly get to the answer but I can fathom a thesis.
Iterative Health’s investors include the founders of Flatiron: Nat Turner and Zach Weinberg. A digital health company that advances cancer research. Pharma company Roche acquired Flatiron for $1.9 billion in 2018. Other investors of Iterative Health include Johnson & Johnson and Eli Lilly amongst others. Further key team members from Flatiron have been joining Iterative.
My reading of the play here is straightforward. It’s possible that investors want to repeat their thesis of Flatiron for Iterative but in gastroenterology. Big Pharma is funding AI in healthcare to develop more targeted therapy for the drugs they develop. Therefore the central premise of Iterative’s offerings today seem to be on better recruitment for clinical trials. Physicians get an ancillary. Pharma automates patient recruitment.
I came away super impressed with Jon’s unwavering vision for AI in GI: equitable healthcare. When I asked how Iterative is different from Medtronic or others who were also working AI in GI. He repeated his vision – he said the desire for equitable healthcare differentiated them.
While on a medical mission in Cambodia, it occurred to him that not all doctors are made equal. And that means patients can’t get fair access to healthcare. Computer vision and AI could change that. He took action.
Jon moved to MIT to study MBA and build on this idea. In a very short period, he developed the foundation for Iterative that went onto pave the way for AI in GI.
Here’s Jon changing gastroenterology for good. It’s reasonable to say that the future of GI hinges on the execution of his vision.
◘  The fascinating story behind starting up Iterative Health
◘  “Not using computer vision is a barrier to health equity”
◘  Why did Iterative Health enter the field of gastroenterology?
◘  How does Iterative Health differ from the other AI companies in GI?
◘  Iterative Health raised $150 million. What attracted investors?
◘  What is their next milestone?
◘  “Right now today there’s an unacceptable level of disparity in (health) outcomes”
◘  “Being able to minimize the barrier for GIs is to be able to access information”
◘  Will AI replace GIs?
◘  How sophisticated is computer vision in the endoscopy room right now?
◘  “For healthcare, it just takes way too long to understand our impact on patients”
◘  Future of AI in GI
◘  “Even our colonoscopy screening recommendations are generic for the population”
◘  Iterative Health’s operational model
◘  Partnership with One GI
◘  Jonathan’s views on the controversial NordICC colonoscopy study

The Transcribed Interview:
Praveen Suthrum: Dr. Jonathan NG, CEO, and founder of Iterative Scopes. Thank you so much for joining me on The Scope Forward Show. I’ve been waiting to have this chat for many months now, so I’m glad that we scheduled it. So let me first introduce you to our audience. So you’re the CEO and founder of Iterative Scopes, a pioneer in the application of AI-based precision medicine to gastroenterology with the aim of establishing a new standard of care for the detection and ultimate treatment of GI diseases. The company is a start-up that’s fun out of MIT, and you’ve recently raised $150M in Series B financing to accelerate the development of your core algorithmic innovations. So that’s exciting and it’s really wonderful. So anyway, John, welcome to The Scope Forward Show.
Dr. Jonathan Ng: Yeah, thanks for having me, Praveen. I’m excited to be here and sorry it took us so long to get here.
Praveen Suthrum: No, you’ve been busy raising the money that you did. So, first of all, congratulations to your team. I think it’s very exciting, not just for you as a company and as a start-up, but for the industry itself, because it’s very telling on the interest that GI as a space is attracting and the direction of where investments are flowing. So it’s very telling. So congratulations to all of you. But John, I want to ask you first about the backstory here. So now you got the idea. I learned while you were on a trip in Cambodia and you were looking at doctors there trying to detect tumours and their inability to find it. And then the idea germinated. I think at that time you were doing your MBBS in Singapore. So please tell us all about it.
Dr. Jonathan Ng: Happy to share that one. It’s quite an interesting story. So I think since I got my start in healthcare pretty early on, just by chance, I happened to visit Cambodia for context. Pretty much first generation college, no one else and family had doctors. But I was fortunate to receive mentorship from a friend’s dad who was a doctor. And he said, John, can you come to Cambodia and carry my bag? Go around. Medical mission happened to be on that trip. And that was my first experience of healthcare outside of Singapore, which is very much a first of all healthcare system. And frankly, it was pretty shocking how the state of health care was back then. It was back then emerging from the Khmer Rouge, from the Pol Pot regime and it was feeling at a very fundamental stage of like. After the Pol Pot regime there were basically two doctors left in the country serving patients and for a population of 12 million people because Khmer Rouge decided that the best way to prevent an uprising against them was to kill off all the intellectual people. And so I arrived in the country that observed how kids were not making it through for really basic reasons. And back then, the under five mortality rate was about 20%, 25%. And I was like, this is totally unacceptable. You can’t know this and not do anything about it. Long story short, I end up in a deep rabbit hole, end up spending about 14years in Cambodia, building all kinds of facilities, open its first paediatric cardiothoracic surgery units, unit awards, for instance, reconstructive units, getting involved in a couple of establishments, establishing a couple paediatric hospitals in rural Cambodia. But as part of this process, we were trying to train Cambodia’s first generation of surgeons. And I would frequently bring in my best tutors from Singapore, from the US. From places like the Brigham Boston group of hospital, and bring them to try and impart knowledge. And frequently we would struggle with this thing where and this thing plays on my mind over and over again, where I would be sending in the operating theatre. My mentor would be standing next to me, and you’d be like, look at this huge tumour. You would describe all the details to me and all the ways in which we could treat it. I’d be like, yeah, that’s a massive tumour. Obviously, I’m lacking all these other details because I’m not as experienced, I’m not as good. And then there was a session with trying to train, and he would be like, where’s the tumour? And we were like, oh, then if you’re not even seeing it, if you’re not even identifying it, you can’t treat it, right? And that sets off then series cascade of decisions that essentially ends up with the patient receiving a very different outcome. There are many ways to go wrong, only one way, pretty much one way to go right in, and the patient would essentially receive a very different outcome. So when I reach kind of like my 12 13 hours by then doing a lot of regional work, and it got pretty frustrating, to be frank, in terms of my inability to feel like I was moving the needle. I felt like I was spinning in circles, right, constantly trying to move this needle. And so I said, yeah, I’m going to take some time off. I’m going to go back to grad school. By then, I had my immediate I was go to a place which essentially was very forward thinking and very a hub for innovation. And that updates MIT.
Praveen Suthrum: Sorry. Just to time this a little bit, you were doing your MBBS, and you were in Cambodia at the same time, so it was happening.
Dr. Jonathan Ng: Yeah. So I started working in Cambodia when I was pretty much 15 years old. So this is the way that yes. And then I continued through military service, continued through med school, continued through medical training. So I was working in Cambodia throughout this period.
Praveen Suthrum: Fascinating. Okay. Yeah, please continue. So now you’re in MIT, and then?
Dr. Jonathan Ng: In MIT, I come there with an open mind, trying to explore all the labs. And one of the first few technologies that I see is the use of computer vision and autonomous vehicles. And I look at it, I’m like, this is fascinating. This technology can identify cats, dogs, humans, cars. And even at the point of time, they were like, we can integrate. If a human is walking in a certain way, we can kind of predict whether the person’s going to turn left and right, dodge it, start running all these complex intuition. And I was like, that’s super cool. But also, why don’t we have this in medicine? Why can’t we have this in healthcare? Because to me, that represented a major barrier to patients receiving equitable health care, right? As equitable in outcome as possible. And that’s, in a nutshell, what I’ve been working through towards for the past, I’d say now, 20 years now. And I was like, this feels like a big one. This feels like a big knowledge gap that back then, we were in today. Still, we’re trying to move medical knowledge. Sure. Medical textbooks. We know that doesn’t really work. It doesn’t represent real world, because we did then we wouldn’t need residency. We do residency, which is essentially apprenticeship, which is nearly a one to one teaching model, which is not scalable and doesn’t really fulfil what the world needs in terms of better health care, more scalable health care. And then we also do conferences, which, unfortunately, I’ve been to a number of these, and for a good number of them, I think, with the ability to educate once a year, the feedback loop isn’t short enough. The examples we use aren’t real world enough, and they’re not really geared towards, like, very fundamental, like, questions like, is this a tumour? Is this not a tumour? Right. People expect for it to be covered in medical school, but it’s also that gap exists very much in a real world today. And I kept thinking to myself, damn, this is awesome technology that we can use. Now, I’m not a gastroenterologist by training. In fact, I was training to be a surgeon, but I kind of landed, worked my way backwards into fascinating technology. Where can we use this? And so they started looking at places which I’m more familiar with and plastic surgery and orthopaedics and cardiology. But I did landed in GI really, because I think for a few reasons. Number one, I think GI doctors are just awesome to work with. I think when you deal with poop and stool all day, I think he just can’t take himself too seriously and it’s just straight out. We all know start-up as a grind. We all know that you try to innovate the grind and you really want to go through that grind with people you enjoy working with. There are set of specialties which I will not name on this record, that I will not try to innovate with. Right. Like they will bite your head off before you try to move and change anything. I think beyond that understanding that GI isa very visually based disease, naturally it’s like surgery but with a natural camera already. Whereas most surgeons don’t operate with a camera or don’t have a primary view of a camera. All these factors played into it and I said why don’t we try it in GI? I think from the very get go and still today I have a broad mandate, I have a broad vision, but in terms of using this technology to close in on disparities and health care outcomes and I think that accounts for what you alluded to a lot of our successes. I think many people see this potential as well.
Praveen Suthrum: If I may ask, how does it differ from the AI solutions that are already there in GI? For example, there’s GI genius from Medtronic, there’s Satisfai Health and there are a lot of start-ups waiting at the gate of FDA from what I learned. And there are newer and newer publications all the time. Even Google has got its interests, they’ve written a paper on computer vision and detecting polyps. So how does your solution actually differ and what part of it is similar to what’s out there?
Dr. Jonathan Ng: Yeah, great question. Sorry. I won’t claim to know every single solution out there. I think the biggest differentiator we have is really the vision behind and why we’re doing this. I think that will eventually we keep doubling on why and we’re doing this in terms of reducing health disparities and health care outcomes. We have a very practical role take on the application of the AI and GI and I think eventually that just leads us into more differentiated space, slightly different angle than say someone who is trying to just sell more snares or trying to do it for maybe sell most products. I’m not sure. I think for us the fundamental reason is very critical and it’s what drives every single decision we make here at Iterative.
Praveen Suthrum: Let’s go back to the name, Iterative Scopes itself. How did you come up with it and get a story here?
Dr. Jonathan Ng: Yeah, essentially I was having too many drinks of my professors at MIT, you know, and trust us to come up with overly complicated names, but I think why ‘Iterative’ firstly, I saw it as a very much a learning journey in the practical sense of, I don’t have it all done today. I expect to have an Iterative process. Iterative learning around this. I think the other part is also the whole machine learning aspect of this. It’s like it’s not one algorithm at this point in time, tens, hundreds of algorithms that are all learning on repeat. And the more times you iterate, the better you become. And so that word really stuck in my head now, the ‘scopes’ part. Here’s some news on this. I think by the time this podcast is out, you’ll get the news that’s what the change? I think to me, it was defining a narrow initial path of GI. First, and to be very clear, the flip side did not realize that would do is I think 80% of the market thinks we manufacture hardware and like, okay, I probably made the mistake. Everyone’s asking me, so where’s the scope you manufacture? I’m like, I don’t know, man. We don’t manufacture anything. But we’re about to fix that. And stay tuned for some news. It’ll be pretty fun.
Praveen Suthrum: I’m looking forward to that news, but I can guess what it might be based on what you just said. But somewhere, John, the message seems to have resonated with investors, with digital health investors. So somewhere the community seems to have taken to your vision. Can you talk a little bit about that? You’ve raised a huge sum of money. I’ve not seen $150M plus being raised in digital GI.I think your start-up is leading that game. What attracted investors to your company?
Dr. Jonathan Ng: Honestly, I wish I knew. I think the breadth of the vision in terms of and I think we have such a strong team in place right now. And I keep saying this since early days. It’s easy to mistake. Everyone has to enter the market at some point. But I think the quality of talent and the vision behind the company will eventually, you know, define where each company goes. And I think for clarity first, I think the market, the GI market is big enough to host multiple AI companies. So I always tell my folks that the competition is not really, say, GI genius or Satisfai or any of that. It’s really ourselves. It’s really making sure that we do what’s best for our doctors and making sure that we understand our customers as well as we should and doing the best for our patients. We’re only fighting ourselves with this one. And so I think what’s the quality of people that we have internally, depth of which we have bottomed out our vision in terms of putting together a comprehensive strategy and our initial successes and being able to execute against them, I think that has all attracted quite a decent amount of money.
Praveen Suthrum: Did you plan to raise this amount when you were at the end of Series A or did it just happen? What is the story here? How did that come about?
Dr. Jonathan Ng: I think it’s a bit of both serendipity and I also acknowledge that a lot of it’s been a huge privilege in terms of this whole entire journey myself. I arrived in the US only four and a half years ago and two years to spend it in school. So it’s been incredible the past four years, three years running this company. I think everyone has plans. It was certainly, I think, a mix of serendipity in terms of meeting the right folks who understood the vision, also hitting milestones, and also being able to show that we were bringing in the right folks. And with bit more money, we could basically strap on some rockets and take it to where we wanted to.
Praveen Suthrum: And where would that be? So what is the Holy Grail for the company? What is the next milestone or the next big milestone from here?
Dr. Jonathan Ng: I think the Holy Grail is if we basically are able to use AI to analytics to basically provide every single doctor with the information they need, and they deserve to be able to treat their patients somewhat equally. Right. I think right now, today, there’s an unacceptable level of disparity in outcomes, whether you choose to accept it or not. Whether you choose to acknowledge it or not. Right. I’ve worked in countries where we struggle to even get basic calls into place. We don’t even talk about identification of serial polyps or any of the store or the level of severity of the IBD right. And so being able to push this information into every single endoscopy suite, being able to minimize the barrier and the activation energy for GIs to be able to access this information and be consistent about it across the board, I hope that this will be a great equalizer in terms of outcomes.
Praveen Suthrum: That’s fantastic for patient outcomes, but there may be gastroenterologists out there who might be thinking, hey, if a technology like this is going to do the job that I do currently, what would I do? So how would you respond to that or any thoughts there?
Dr. Jonathan Ng: Personally, I don’t think we’re trying to replace anybody here. I think we’re providing information so that folks can do what they do best, which is treat all of us, sign up to medicine, to healthcare, to treat our patients, to help someone. Right. And why would you turn down being able to knowledge and data that is able to help you to drive better outcomes? We’re not saying we’re taking over, for example, the mechanics of driving a scope. We’re not intercepting the polyp for you. We’re simply making recommendations, making it easier to have a common identification of polyps, common identification of certain procedures, common assessment of certain diseases, so that we have good understanding of how these patients should be treated. That’s the way we see it. We’re not going to take away what GIs do today. I think that’s impossible.
Praveen Suthrum: But let’s go back to that analogy of self driving cars that actually prompted you in this direction. You may be familiar with the five levels of self driving or autonomous vehicles. Somebody’s given this classification. I find it quite interesting. I even wrote about it in Scope Forward. So the thinking on my question to you is that what if that were to be applied to computer vision in the endoscopy room? So if you were to apply from level 1 2 3 4 5, which has increasing levels of sophistication where would you land when you apply computer vision to endoscopy?
Dr. Jonathan Ng: We’re right at the start right now. It’s very rudimentary what we’re doing. And I think for healthcare, it just takes way too long to understand our impact on patients. Like, imagine this early to put cars, these cars on the roads. We’re just barely standardized. And roads are pretty straight. Roads have, like, standardized stop signs. Roads have crosswalk. So people actually go across. Now think about anatomy. There’s no crosswalk. Everyone’s anatomy is different. If you had bowel surgery before this, it’s completely different. I think it’s going to take us tens of years to get there. The totally autonomous situation. Everything told them is an identification of patents. And just being able to support.
Praveen Suthrum: That’s interesting to know. I usually ask this question towards the end, but I think I want to ask it now. So if you were to throw a stone and that way to land, let’s say five years from now, and then three years from now and then next year, one year from now, where would it land in terms of AI, in gastroenterology? Let’s start with five. Let’s start with the distant future. I’m saying five is not even too far out, but how far would we go in terms of AI and GI? Five years from now? And then I just want to follow that up with three years and then one year.
Dr. Jonathan Ng: I think five years is pretty short term for us. There’s a pace of change in healthcare is pretty short. Okay, we might have certain great polyp detection algorithms, certain features being detected, certain historic being predicted, for example, and use in certain clinical decision making. But I suspect that’s where we’re going to be here in five years time. And that’s it. I’m pretty conservative with how fast technology moves. I know there’s some visionaries out there that are like, oh, we’re going to be self driving these scopes through a colon in five years time. I think no.
Praveen Suthrum: Then let’s extend the horizon. Like, five years is short term, and that’s what you’re seeing, what is increased sophistication from that point of time, let’s push forward to ten years.
Dr. Jonathan Ng: I think being able to, for example, ingest multiple data sources that are now becoming more and more available. So, for example, we’ve got all these like Guardant or Freenome and all these liquid biopsies, for example, right? You know, being able to ingest from various tests and being able to risk adjust, being able to take a comprehensive view of a patient, being able to ingest various multi model data sets to then come up with a more balanced view of a patient more comprehensive view of patient will be an incredible outcome if we can get to in ten years time. Right? And I think that would be a great application to be able to have personalized recommendations right now. Even our colonoscopy screening recommendations are generic for the population. Folks who ask me every time, like, what age should I start scoping? And I’m like, as soon as you can afford it, you should scope. Because I have friends who have had stage four cancer at 35 years old, right? And I’m like, I don’t know if it’s not going to be you, but I certainly hope not. And the only way that it’s not you is if you get a colonoscopy. So if you can afford it, go scope. Peace. I’m going to get my first colonoscopy next year at age 35. But instead of generic recommendations to come up with true risk predictors, to come up with a comprehensive view of the patient so that we are able to confidently and individually make these recommendations, because right now, also the way we do healthcare, because the guidance is so broad, seething, it just becomes so expensive. And so there’s a sweet spot where we can understand each patient, we can customize our recommendations for each patient, and then we can in between that apply preventative measures to just keep monitoring in between.
Praveen Suthrum:  So currently, what is the operational model? You’re not yet selling in the US, are you?
Dr. Jonathan Ng: So we do have a product in the US. It’s a bit of a patient identification algorithm which basically identifies the right patients for the right clinical trials. It’s currently in working in inflammatory bowel disease. It’s a pretty cool piece of technology. We’ve got quite a few sites deployed right now, and it’s been a tremendous year for us in terms of that site deployment, and we’re really excited to see what it brings for the next 20 years.
Praveen Suthrum: But you’re not using the polyp detection tool in the US.
Dr. Jonathan Ng: That’s not available in the US. So we just got cleared with the agency and it should be commercially available pretty soon.
Praveen Suthrum: Okay. And I’m assuming that would be next year.
Dr. Jonathan Ng: I believe it’s very early today.
Praveen Suthrum: Now, you’ve raised all this money. Other than building up the leadership team, how are you deploying it? What happens over the next, let’s say100 days and twelve month period?
Dr. Jonathan Ng: I mean, 100 days pretty much it’s too short. Again, we don’t think in that short term. Right. Again, the capital we have raised upwards and allows us to do that. So we’re very, very privileged here, I think. We think very much in terms of years where we want to go, I’d say we’re doubling down on GI. We’re not going anywhere. Right. We remain extremely focused and we’re excited to engage more with a broader swath of the community. For example, we’ve got great partners. We just announced a partnership with One GI, the One GI platform, which is, you know, they’re really, really awesome people. And Robbie and Zia, we love working with them, and we want to find more partners like that. Right? We want to find ways in which clinicians, who are even CEOs and administrators who are interested in moving the needle forward, not just for themselves, but for many others in the world, to engage with us and to be able to help us understand what would make a difference to the practice and allow us to create tools against those. I think that’s very much on our roadmap.
Praveen Suthrum: Got it. And these partnerships with GI practices, it’s primarily for recruiting patients for clinical trials. Is that the scope of the partnership or is it beyond that?
Dr. Jonathan Ng: We’ve got a number of other programs as well, R&D programs. We’re exploring a good number of novel endpoint and novel ways of measuring disease severity and such that.
Praveen Suthrum: So, John, the last few days there’s been a flurry of news in GI as a result of the Nordic study that was published by NEJM. And as you know, the study questioned the effectiveness of colonoscopy and linked it to deaths associated with colon cancer. What did you think of it and what did you think of the reaction on both sides of the continent? There were people on the European side who commented. There were GI societies on the US side that commented. So I’m curious to know what your take was when you read all that first-year. is your product currently commercial or when is it going to launch?
Dr. Jonathan Ng: I applaud the office for putting in all this effort, and it’s a ten year study. It’s incredible how much effort has gone into it. I think it’s a much-needed study. Unfortunately, I think the title was pretty much dictate. I think there are many ways in which we could have framed the title more responsibly so that the general population who reads it actually goes beyond the title to understand what’s in the study and what the actual recommendation or findings were. I think certain things spread out, and we’ve known this for a while around, say, for example, certain GI populations having lower detection rates. And that is the key thing we’re trying to address here in terms of, yeah, maybe everyone maybe if you have lower area rates, either we should do some population studies in your population or perhaps they just have a lower propensity to get cholesterol cancer, which I don’t think is true in Norwegian population. Or we should help them with polyp detection algorithms, perhaps, and maybe start deploying some of these tools into their systems. But this is an biological  difference that we have known for some time I mean, we’ve seen other studies, for example, done in Italy, where the devices approved from Italy for Italian studies, for example, that have a completely different patient population. You know, we tend to be aware that these differences do present themselves. I think historically we try to have more balanced view of studies. I know studies are how you design them, essentially, right? But essentially for ourselves, we tried to personally stay away from the design of the study and had more clinical advisors, more balanced advisors come in and help us to design it. So, for example, in our most recent publication in Gastroenterology and the foundation in September, it was a five century RCT that was done across, you know, it was MGH, it was midsized academic hospital. Below that, there was a large PE practice based, large PE rollout type practice as well as a community GI type practice. And we saw a fascinating range of outcomes. I’m sure there are reasons for that, but we want to be truthful of ourselves. We want to make sure that representative against population we’re deploying against.
Praveen Suthrum: One of the comments that came out on the US. Side was about the ADRs, and that the ADR of the endoscopy was lower. When I did that, I was thinking, shouldn’t we actually mandate using AI tools for endoscopy so that the ADR across the board reaches a certain baseline? Do you think that should happen or is it likely to happen? Any comments?
Dr. Jonathan Ng: I wish it happened. It’s why we are here. It’s why we’re present. I think it’s a two way street. I think as much as regulators and insurers and payers should regulate it into existence and to broader assistance, I think the other side of this is engaging us and for us to minimize the barrier to adoption. I think a lot of AI right now is current for would be infeasible or overly expensive for most of GI practices to adopt. And I think we as a company have a responsibility to try and in the spirit of our mission, trying to reduce or minimize this barrier to adoption. And that’s what we’ve been working towards having again.
Praveen Suthrum: John, this is great to have this conversation. I think it gave me a great perspective on how you’re thinking and how the company is thinking. Is there anything else that you wanted to share?
Dr. Jonathan Ng: No, we were just really excited to keep innovating. We’re always looking for good partners. So let us know. Hit us up if you’re keen to work with us and we’re keen to understand our products and yeah, pretty much, we’ll keep going.
Praveen Suthrum: Congratulations once again to you and your team, and I look forward to catching up again.
Dr. Jonathan Ng: Yeah. Thank you. Bye.

_

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08 Nov 2022

Dr. Michael Owens: “What would I do with my time if I am not doing as many colonoscopies? It’s an interesting thought experiment”.

Dr. Michael Owens:
“What would I do with my time if I am not doing as many colonoscopies? It’s an interesting thought experiment”.
Gastroenterologist Dr. Michael Owens did a thought experiment during the pandemic period. He asked himself, what would I do with my time if I’m not doing as many colonoscopies?
That question led him to leave his large GI group to start up a multi-specialty GI group that takes advantage of the trends shaping the future of GI. For example, trends such as value based care, the microbiome, AI, colonics, single-use devices, genomic tests, liquid biopsy and so on. As he implies, Mike literally implemented the central premise of the book Scope Forward to build future on his own terms. He stands as a great example for GI 2.0.
We often limit our choices to what’s prevalent in the market. Join a hospital. Join PE. Merge with a large independent group. Kudos to Mike and his partners at Pearl Health Partners for having the courage to go against the grain and take a different, innovative approach.
He says in the interview: if not now then when?
◘  Backstory on how he got started
◘  “I think the Northwest has been somewhat excluded from a lot of the M&A and a lot of the PE involvement, but it’s happening”
◘  The larger the organizations, greater the complexity
◘  “Seeing what was happening in the surrounding states with PE and not knowing where that was headed, the desire to take control of your own situation sometimes kind of bubbles up”
◘  “We’re watching Cologuard and we’re watching a lot of the world shift”
◘  “I felt like there were more opportunities here to look outside. What would I do with my time if I’m not doing as many colonoscopies?”
◘  Why did Pearl Health Partners choose the multi-specialty route?
◘  “We are able to bring in investors at a pretty low EBITDA”
◘  Is the multi-specialty model better than a single specialty GI model?
◘  Innovations
◘  “We don’t have a group of 60 doctors with 3 committees taking 6 months to pick which prep we use”
◘  “I think we have a lot of incentive to not do fewer colonoscopies out there”
◘  What changes will private practices or GI as a space see in the next 5 years?
◘  “AI is going to be just sorting a lot of the complexity for us”

The Transcribed Interview:
Praveen Suthrum: Dr. Michael Owens from Pearl Health Partners. Thank you so much for joining me on The Scope Forward Show. I’m really looking forward to our chat today.
Dr. Michael Owens: Good to see you, Praveen. Thanks.
Praveen Suthrum: Mike as we get started, I want to first introduce you briefly and I’m taking this off from your LinkedIn profile. So you’re now the co-founder of Pearl Health Partners and you’re also the director of Digestive Health for this new company. But by way of background, you’ve had a long career in interventional gastroenterology and now you’ve built this new organization. It’s an independent health organization that’s focused on value-based care. You’ve got two surgery centers and you’re working with multidisciplinary specialists. And you say you have a novel model for the business of medicine, which I’m really looking forward to learning. And then you’re expanding in the Portland metro area. What is fascinating for me from your profile is that now this is your former private practice GI and now you’re part of this whole multispecialty GI entity. So I’m looking forward to learning all about it. But as we get started Mike, what is the backstory here? How did all this happen?
Dr. Michael Owens: Thanks for giving me a chance to talk to you again. I think that we have a lot in common and I think we shared some conversations that were pretty interesting so far. After reading your book Scope Forward, there were other people out there that pre-pandemic who had similar thoughts to me. And I wasn’t really aware of that until very recently, but that’s a part of it. I think that there’s obviously been pressure the past four or five years in many regions. I think the Northwest has been somewhat excluded from a lot of the MnA that’s been going on and a lot of the PE involvement. But it’s happening especially up north of us in Washington, what used to be how do we kind of build out our indoor lab and how do we get in our ancillaries and how do we look at our service lines and how do we bring some of the tertiary care into smaller places? The conversation started changing. It was a lot more pressure from outside institutions that they were aligned with. But things were changing in the employment models in hospitals wanting to joint venture more and more and a lot of money exchanging hands in different arrangements. And along with that, I noticed that there were pressures on the revenue models that we’d all expected. And I think we’ve all thought about this for a long time. And I’ve always been a look down the road, two to five years kind of person. It’s maybe my sweet spot. And thinking the larger organizations were getting, the more complexity was coming into what the doctors wanted to do every day. And it’s what we’ve all felt, we can’t get the extra nurse that we need, we can’t get that extra amount of time to do the other thing. And so we all feel like the glory days maybe of independent practice started to make us feel a little bit of anxiety about where things were headed. And I realized there are so many physicians coming out of training who are really kind of embracing the employment model because on the surface, it appears easy. A lot of the headaches are not there, a lot of the worry isn’t there. It’s secure. And if there’s anything the past couple of years have taught us, the securities of employment and salary seem wonderful, especially when there’s so much upheaval. So I had been a therapeutic endoscopist for almost 20 years. I’d spent three days at the hospital and really enjoyed that world to the point that I did a lot of extra work in different aspects of interventional. Throughout the year, we helped work on service lines, building an advanced endoscopy center. We became one of the 30 pancreas centers in the country. Our ripple volumes were doubling. We brought in more surgeons. So I really wasn’t sitting in the normal space, I think, for gastroenterologists during this time. So 2021 or so, I have an opportunity to join some other docs in buying into a surgery center and seeing what was happening in the surrounding states with PE and not knowing with my position previously where all that was headed. The desire to take control of your own situation sometimes kind of bubbles up. You hear a lot of people coming out of the pandemic have said, I just wanted to try this, and if it doesn’t work, it doesn’t work. But if you don’t do it now, when are you going to do it? And so we spent about six months playing with the idea, making an offer on a surgery center that had not really got up and running before the pandemic hit, and it was sitting unused. We had a small plan at first about how we might turn this into an interesting opportunity, and it grew fast. We ended up bringing in a number of different people who were very similar in their experience and age, but were surgeons, many of whom I’d worked with for a long time. And these are relationships maybe because I was doing interventional work. I think interventional and therapeutics may be a different world a little bit for many people and maybe that’s where the outbreak came from. All of these ideas when you start to put yourself into how would I do things different, how would I do things better? What do I think the risks are? Your whole book is in my head as I’m looking at, okay, colonoscopy 2021 probably is going to impact, who knows, 20% to 30% of our recall cases when the new USPSTF guidelines come out. We’re hearing alternative ideas anyways. We’re watching Cologuard and we’re watching a lot of the world shift in all of the genomics that are happening. And I really thought there’s a good chance that we’re over utilizing Colonoscopy, that the world is coming together to probably impact that in the next how many years on a two-to-five-year thinker kind of. And it seemed like it was going to hit in that window because of that and because it did not been like the mainstay of my day to work, I felt like there were more opportunities here to look outside. What would I do with my time if I’m not doing as many colonoscopies? And it was refreshing. It’s like a thought experiment, right? So I really was excited about what was happening with the microbiome. I was very interested in weight loss and our failures as GI doctors to really spend time on it. I think a lot of people thought that that was a primary care diagnosis and treatment algorithm, right? I was very interested in how I can work on service lines with these other doctors that I used to have to send patients to and it would take them forever to get seen and they were in a different institution. So we started looking at pelvic floor, pelvic floor dysfunction. We started looking at women’s centers and what are their needs and all these overlap ideas started to happen. There were some business thoughts there too. When you have a primary care market that’s a bit controlled by health systems, some of the women’s clinics are kind of a backdoor. They have tens of thousands of patients, but they’re really being asked to provide the primary care. And I think that there was overlap with a lot of the surgeons working with who I’ve worked with for years, who do endoscopy. And we started looking at what else can we do in helping our ENC docs and our folks that have issues with sleep apnea and hydro hernia and they need weight loss. Again, it kept coming back to what if this all was kind of a new way of working together. We had the benefit of, OK, let’s build this around a surgery center. We saw the problems with the hospitals being able to provide access to care and we thought, okay, we could be the last man or woman standing in this ASC if we build this right? So that more procedures move to that space, everyone wins.
The co-founder of Pearl Health Partners is a dominant named Richard Rosenfield. He’s a GYN surgeon who pioneered outpatient Laparoscopic Hysterectomy same day discharge. He’s worked on other aspects of medicine for a long time relating to the business of medicine and a lot of it repairs, bundles, ERISA plans, things that I didn’t know much about. But as we started looking at how value-based care is or isn’t really value based care, and we saw people bantering about transparency, we saw hospitals not complying, we saw payers that kind of wanted to comply. We started entering relationships with some of the organizations that are doing deep data mining and cleaning of the data and they’re doing different market analysis now. And we all realized we kind of know our numbers and we think we know what our price targets could be to be cheaper for the patient and the payers, even if it’s just a high deductible situation and colonoscopy is a little different, it’s a high-volume situation. But some of the other things we’re doing in weight loss aren’t they’re kind of a little more surgical and putting together a bundle that is going to be something that is either a cash pays or you’re going to build it into new things. We’re going to find a way to get to payers and say, look at what we’ve done. We now have long term results that are worth us considering some of those things. So we had a component here of the business that was 15 years into the process of trying to deliver care in a more affordable fashion with high quality. And we were right at the peak of when transparency was finally starting to get to some real hooks, I think. So all that kind of came together into these big ideas of what if we took the best folks we know that we’re kind of aligned and we work together and we had a very easy entry into a surgery center. Can we make something like this happen? We then went to a bunch of consultants, and we started kind of getting an idea about who we might want to talk to, who would be a corporate partner that was thinking a little different in the space. We are intending to use our existing business to build out as a business service, all under a tax ID, slowly assimilate the practices as much as we can. You want consultants that have done this a lot. You want people that can guide you and not down the wrong path and pivot if you need to. And I think that’s been very key. We would like to see that. At the end of the day, we’ve executed our steps and our business model has exit ramps. We thought long and hard about this and we do think that you get a target on your back for acquisition when you do this. No matter who you are. Maybe because the way that PEs approach different specialties they’ve gotten through Derm and Opto and Ortho, you know, and their GI was the hot girl at the dance for a while here and it’s going to move on. I mean, I think that there’s going to be other things. So multi-specialty care, there are other areas in the multi-specialty space. When you look at who would you want to bring in like cardiology, there are definitely some things that are changing a little bit and you want to have enough autonomy to continue that path, enough ownership and equity to allow it to be a rewarding independent group. And then you’re going to have to figure out on the corporate side that there will be some ownership, there will be capital, there will be other things that come in for growth purposes and eventually you might end up looking a little more like another existing organization out there. But not GI single specialty probably.
Praveen Suthrum: Let me clarify a few things. So first things first. You didn’t go for a single GI specialty type expansion. You went the multi-specialty route. And I do not know of any other Gastroenterologists in the country who has dropped out of private practice and started up another entity with multispecialty group with the intent of focusing on value-based care. So congratulations on that. Now my question is how is this all funded? Is it all self-funded by the physicians? Did you have to raise money?
Dr. Michael Owens: So we were in this enviable position that our cofounder had an ASC that did mostly GYN, plastics and had done a number of other pain and a few other specialties over the years. It was already capitalized, it was already just went through recertification and contracts were already established. Now maybe contracts need to be renegotiated because we have a bunch of new things and that’s in the works. But we’re able to bring in investors at a pretty low EBITDA because the goal here is to allow more people to become involved because the end result is the key. So you don’t want like a high barrier to entry if you don’t need it and to immediately start work, you get credentialed there wasn’t a ton more capital in the or needed and immediately start generating revenue. We have our banking relationships; we have our next round of syndication closings will be round two. And so the physicians are basically funding the practice and then the remodel of a second center with their equity shares essentially. So this was tailored just to our specific instance. Would it work like copy and paste around the country? It will be very different. I mean, I think if you said let’s do this from a de novo pad out in the middle of a suburb and you were going to put 5 million into an ASC, you’re going to have a lot of different capital needs, right? We are in a situation. We’ve got confirmation today we’re going to be able to expand to our second center with the same tax ID under Medicare. So we have our contracts and it will really not slow us down as much as it might some other situations. So it’s kind of an expansion that is de novo situation. But we did go through a very lengthy process on articles of incorporation and the operating agreement to set up this particular version, I guess, of how you would model it.
Praveen Suthrum: Got it. And I’m assuming your partners I’m asking this because I’m sure other people will have similar questions. So the partners in this venture, I’m sure they were already part of other practices. There are other specialties, other practices. They might have been part of other surgery centers. So have they left that and come on full time this venture or are they still doing that and then this is part time? How does that work?
Dr. Michael Owens: They are all independent practices. So they each have, I think we have nine different practices now. And so they each have all the components of their practice. They each are very interested in the benefits of us taking over time, all those practices under one roof for reasons everyone can imagine, right? And I think that’s where more opportunity has presented itself. So we had these steps of one surgery center cranking you’re there. It’s not big enough for all of us. We’re going to have our expansion coming. We have the business putting our practices together. How is that going to benefit? As you can imagine, things that people really want. They want to get that network effect for leverage, for contracting. But we’re bringing in the transparency data. We’re going to try and look at this from a number of different angles because of our timing. We may try to align sooner than we bought on some of those things. But it’s been almost entirely group dynamics, opportunity, the people involved, and I think for innovative thinkers, but I think it made it easier for us to convince people to come together around this. And the pressure about that independent practice is not an insignificant part. I think the ability to say we all feel the same, many of us have been through similar kinds of things and see the opportunity to try, like it or not, to maintain an independent practice as long as possible is worth it.
Praveen Suthrum: Like you, your other partners also did not want to join private equity groups or the hospital or larger groups. They do not do that. Okay.
Dr. Michael Owens: No, they’re very much aligned around the idea that maintaining your autonomy and independent practices it is and how they’ve done things.
Praveen Suthrum: Now Mike, other than the business aspect or the business arrangement itself of coming together in a multi-specialty environment, are there any correlations that you’re seeing in terms of patient care itself? Are there any links that you’re seeing from GI to some other specialties or it’s too early to say all that.
Dr. Michael Owens: That’s been very clear with the women’s clinic and women’s care, whether there’s in total amongst a couple of the practices and there’s some things in development might be 10,000 patient lives and fatty liver is a giant issue, as you know. And that was an immediate alignment amongst four or five of us, the pelvic floor, endometriosis and our colorectal surgeon, our pain specialist GYN, GI, the way that our work in the microbiome overlaps in a lot of this care. But what’s missing, we are not yet looking at complex IBD, some complex liver disease. We’ve not built around those ideas because we really were required, and I think it was an intentional choice to build around outpatient procedural and surgical care first because that’s kind of where the business model evolved from. It is a little more surprising how much the clinical care aligned. It happens. I mean, our GYN surgeon just the other night was in late at the hospital taking care of a patient and just happened to bump into one of our foregut surgeons and was like, well, what do we think about this? And she’s like, Let me have a look. That’s like any good group, I think any larger multi-specialty group employed situations, you would see those interactions and alignment. I think the difference is we’re in control and I think when it comes to price points, we all can look at each other and say what makes sense? Because you have three hats on when you’re sitting there thinking about this, right? You want to deliver that value-based proposition. You got to support the centre so that it’s functional and you don’t lose money. So you’re trying to figure out where is that sweet spot? And we keep sort of finding it. I think that there is when you look at it from a procedural aspect, it’s easy to wrap your head around the costs and it’s easy to figure out how to bundle things together. It’s a little harder when you’re looking at it from a payer’s perspective or a hostel’s perspective and looking at the total service line as a silo. I just think there’s different inputs and outputs from those thought processes.
Praveen Suthrum: So you’ve talked about pricing transparency and negotiating with insurance companies and so on. So is this model lending itself better than let’s say a single specialty GI model to negotiate better with insurance companies. Or is it again.
Dr. Michael Owens: But I can say that the sessions that we’ve had on a system level with different people who are not physicians. Who are in administrative roles and financial roles. It’s very attractive when people are looking at strategy for their health systems and their health plans. They found this type of innovative thinking to be very attractive as it materialized in a way that I can give you numbers and like, everyone should do this. Of course not. And we’re aware that those are moving pieces and it’s very difficult right now because I think everyone’s trying to sort out what is the future and what do we do and if there’s any criticisms of what we’ve taken on. It’s like, okay, well, what about your Crohn’s patients? And it’s like, well, we’re just not yet building the program, but we’ll get there. What about other specialties that are not proceduralist? You know, well, that might be difficult because we’ve had to build this around the ASC space. Where will we bring those in? So, for example, Endocrinology makes a lot of sense in our comprehensive weight loss program. How do we bring them in? We’re going to have to wrestle with some of that piece by piece. If you’re an existing multi-specialty group, which there are many, you’ve seen how they run their ASC, how things move around in the financial pieces. So there’s some trade-offs and ideally there’s a different delivery system of healthcare in the US. And it’s not fee for services and a lot of this gets solved. But in the meantime, here’s what we can do. And so that’s what we’re putting our efforts into.
Praveen Suthrum: Can you outline what innovations are happening in your business that are different from other multispecialty or other private practice companies and so on.
Dr. Michael Owens: Other than, you know, bringing together all these specialists under one tax ID, working together to deliver care at lower cost, which is part of the biggest innovation. The GI related areas, I think that have changed because I got to rethink colonoscopy from the ground up. We decided to do things a little different. We don’t have like a group of 60 doctors with like three committees taking six months to pick which prep we use. So there’s benefits, right? We rejiggered our day around our ASC because there’s not as many people needing to get in to get their cases done from the physician like productivity side. We’re doing mostly same day preps and we’re doing that 5 hour before the two-hour NPO window. And it’s been going great. And patients love it. I love it. I’m not having people up all night. They’re not calling me all night; they’re not suffering all night. That has been wonderful. Now in the morning we’re doing uppers, we’re doing our diabetics, we’re doing our constipation patients, right? So we just kind of like piece that together a little bit different and then we’ve been able to move a little bit faster. We just saw and are going to do a little pilot with the happy colon, low residue food prep for people that don’t necessarily want to have clear liquid and then a morning day of prep high GI care, which is finally like a little bit more accepted. I know there’s some variability in the data of hydrotherapy for colon preps. We have people that are touted to be experts at colonics in Portland, Oregon. And so I’ve been learning all about that world and it’s fascinating that we were so against the idea of clinics and danger, and these are real concerns. But there are people who’ve been doing things in a way that, like, doctors in medicine just haven’t thought. And so will that become like, another great area of care while we’re getting data? Now we’re getting it from large PE firms and GI groups that are building centers for IG Fair. And it may not take off, but it’s starting. But what’s more interesting in our microbiome work, if you take the Effluent from a colonic and you study it with a spontaneously passed stool, the diversity of organisms is not the same. So we really kind of thought more about what can we do different for the patients, for their procedure. We looked at all the single use devices that are out there. We are waiting, really for the prototypes and then pricing to decide. Is that where we’ll head? But here’s an opportunity as we’re going from one to two to three to four rooms. What if we don’t want to drop three to $400,000 a room when colonoscopy volumes may go down 30, 40% in three or four years? Doesn’t make any sense.
The quality programs we’ve done all the ASGE basically level quality programs to maintain our data. However, I think that we’re being clear with patients already. Why do you want to have your colonoscopy 45, 55, 60 that first colonoscopy, and we’re seeing Cologuard. Now they’re doing 750,000 tests a quarter. You kind of know where that’s headed. There’s how many hundred? Some companies, 150 working on these approaches. Right. You’ve had people on talking about the RNA based approach and there’s folks looking at the microbiome and poly detection, which is insane, but it’s not bad. And we know these things will slot, and I think we have a lot of incentive to not do fewer colonoscopies out there. And, I mean, the PE world has brought that to the table and their arbitrage events and second bites and how that will look. And I think some of the folks that are national societies and point out, like, the flaws and some of the data which are real, but they’re not assimilating at all. I mean, there’s really no reason to think that someone who is put into a low-risk category with their first colonoscopy, which is like 90% right. AI altering like, 3% of the patients into like, a high risk scenario is not going to save us in colonoscopy. Right. And what’s even funnier about that, if you think about it, colonoscopy has a certain performance characteristic that it was only able to do so well at seeing so many polyps. And if that lower performance test saw three small polyps, that was high risk. Well, if you have a new test with AI that can double the ability to detect those little things, it doesn’t mean that person is high risk. When they get to three, it might be ten, it could be twelve. Because now you’re seeing the things that you didn’t know were there before. And with the old test, you knew you could now wait seven to ten years. You can’t say, well, I’m going to go find a few more with AI now I can say they’re high risk, right? It’s a different test. So I think that a lot of this is going to end up in two to three years people becoming more and more cognizant of alternatives. I think that if you read Exact Sciences quarterly reports and you listen to their earnings calls, you kind of get a hint on where they’re headed. They’re already saying, the Blue-C trial, they could stop today and probably use that data, but they’re going to keep going until next year. I think we should all be honest, really going to want to look at what we’re going to spend our time on. And so there’s a bunch of thinkers out there think, you know, are like me. They have the time. They don’t have that pressure to meet their RVU in an employee position or whatever their partners in their large group want them or their PE firm wants them to do. You’re bringing all these people together to think, okay, what do you do with your time? What are you going to do with the specialty? And it’s like, oh, my God, why have we not paid attention? The microbiome is enormously interesting. It’s like our world, and we’ve not yet really accomplished what we need to.
I just finished watching today, the Illumina Genomics conference. One of my colleagues from WashU, J. Wilson, at his CMO at Quest Diagnostics and just talking about where they’re headed, looking at Pharmacokinetics. And he said the problem is everything has been built for the provider in the hospital, but not the patient. So they’re basically getting pharmacogenetics to the patient, who then takes it to the pharmacist, who then says, here’s the drug issues, here’s the dose, here’s what you need. And then they’re calling the doctor to let them know, here’s what we found. They’re like in running around that to bring genomics to the masses. If we’re going to be doing Cologuard, you know, eventually if this is a part of the primary career world, we’re going to get cut out from the decision making and then think about how they’re delivering panels. So you may not really like the Cologuards out there or the next epiphy propoline, but it’s a panel now with 15 other common cancers. So parent care not going to do that. And maybe they still believe in colonoscopy, but now you have this result from the genomics test, and the patient wants that, where are we going to fit? And I think it’s going to be patient risk stratification. There was a recent study from Asia where they tried to kind of do a little bit of high risk, low risk. Where stool testing with entity A go into the algorithm? And it was 75% accurate for advanced polyps in low-risk people, right? So I love the idea of thinking about these combination strategies, risk stratification as the performance characteristics of these nonvisual tests go up, which they will because the science is real, the cost goes down and all of a sudden your compliance goes up and then it’s a win for the disease management and it’s a win for the patient. And I think GI docs is going to have to think about this is win for you. This is time for you to like, let’s look at the bigger picture of what else can we do.
Praveen Suthrum: It’s concerning. It’s amazing. It’s all these things together, right. Final question, Mike is, and you’ve been talking about it, I think you dropped enough clues throughout this conversation. But if you look ahead, not just two to three years, but let’s pick a number like five years from now, okay. What changes do you see in private practice, Gastroenterology or GI as a space as a whole?
Dr. Michael Owens: Well, if I were I don’t think he was pessimistic, but when Larry was on recently and he pointed out, you know, people have their head in the sand and the colonoscopy factories, et cetera, I would wonder about five years, I think for sure. I would wonder what are we going to do with all those GI rooms and what are half of my partners going to be doing all day? And I think that one thing that maybe a little cynically makes me feel like this model we’re building is interesting. I have seven people doing endoscopy and colonoscopy, but half of them do surgery. And we used to look at that as competition. We used to look at it as turf battles. The training is different, but it’s changing a little bit over time in big centers. And the trainees coming out are really somewhat very talented endoscopists, but they can do a lot more than I can do as a GI doc, too. They have this whole other area that I don’t have now, probably that’s complimentary because I’m going to have a GI team that is way down the road on the microbiome and Chrons. We’re not going to be ignoring it anymore, as you pointed out, I think in your newsletter right, there’s already almost a $2 million raise for the Gusto the probiotic like proprietary mix and the mouse model benefits are all that we have. But the data is kind of sound. It’s been there. That will probably get there. Therapies and monitoring are going to finally address weight loss, right. And it’s not just genomic, right. We know that there’s these phenotype variants that are happening somewhere between nature and nurture that we’re going to need to figure out and we’re starting to sort out some of those different phenotypes, right?
I think that there’s going to be areas of therapeutic endoscopy that are very specialized and are really going to continue to move towards working more and more with a lot of people that are not really just gastroenterologists of the old version. Like we mentioned, I think once in our last talk, AI is going to be just sorting a lot of the complexity for us. I don’t think we’re going to be finding a lot of little polyps that really aren’t going to make a difference. It will be this person doesn’t need a colonoscopy because these panels from the microbiome are telling us this person is okay and we changed their diet and they got more bacterias and the thermophilities is lower. Right. I think those are probably the angles we should look at and maybe we’re spending a little more time with the patients. We’re going to be comfortable with a little less revenue because our quality life and our intellectual stimulation is going to be so high. We’ll have less repetitive motion injuries. I think those are all very possible. Will there be independent practices still? I don’t know. We’re going to try.
Praveen Suthrum: No, I’ll reserve my thoughts for later on whether there would be independent GI practice, but just very quickly. Yeah, that would be there will always be the old with the new because there will be some aspects of any industry that will not change or that will take a really long time to change. But in closing, Mike, any final words of wisdom, like in a minute or two to people who are out there who might be in your shoes from, let’s say, 2020, from a couple of years ago when you were contemplating reflecting and you were at crossroads deciding what to do, what would your advice be to them?
Dr. Michael Owens: Because I think I’ve had these conversations lately. I think if you’re bringing on capital, if you’re going to bring on a liquidity, you’re going to bring on other people that are non-clinical. Think hard about that because you really can and maybe should maintain ownership amongst people who are providing the care and generating. And you really have to think carefully about the value of large sales where you’re losing autonomy and what the value really is. And I think that the PE firms and VC that’s coming behind them are thinking that way. And I think that if you’re in a situation where your group does still decide to go down that path for maybe the typical reasons of exit strategies for some of the older docs we’ve seen down the road, what kind of happens. Start thinking about these other models where you maybe two or three of your other aligned physicians in your doctor group start looking at what else could we do here? Right? So try and maybe not give away the whole boat. And if you’re in a group where you do start talking to your folks that you think are aligned about what are we going to do next?
Praveen Suthrum: Mike, this was fantastic. I really enjoyed listening to your views again and some of these conversations we’ve had before. But the way you’ve outlined and connected the dots, I’m sure many in the audience would benefit from it. Thank you so much for coming on The Scope Forward Show.
Dr. Michael Owens: Thank you so much. It was a pleasure. Thank You.
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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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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?

_
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.
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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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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.
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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.
_
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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