When Steve Axelrod took a break from a meeting in San Francisco, he happened upon the Kenneth Rainin Foundation’s research symposium on Inflammatory Bowel Disease (IBD). His company, G-Tech Medical, was developing a device to monitor gut motility for IBD and other gastrointestinal disorders. That serendipitous encounter in 2016 led to the Rainin Foundation’s first grant to a start-up company. It also seeded essential connections, which led to collaborations and clinical trials, published research and FDA approvals.
G-Tech Medical’s device, dubbed an “EKG for the gut,” is a wireless, wearable patch system. It could transform how doctors monitor changes in gut motility and how patients with gastrointestinal disorders understand their disease. The aim is to improve care and therapeutic outcomes for patients and reduce costs by monitoring gastrointestinal tract activity continuously and non-invasively over several days. While it has a number of applications, the ultimate goal of the system is to help quickly target the best treatment for IBD patients.
I talked with three people at G-Tech Medical who are developing this promising technology: Lindsay Axelrod, Staff Research Associate; Dr. Steve Axelrod, CEO; and Dr. Anand Navalgund, Director of Clinical Science. They discussed the impact of early funding, exciting data emerging from current studies and growing interest from researchers and industry. Highlights from our conversation are below.
A Patient-First Philosophy
Anand: When we came to the Fogarty Institute , Dr. Fogarty would repeat this mantra, “Patients first, patients first.” That has been a driving philosophy. Patients have most of their symptoms when they’re at home or work, not at the doctor’s office. We have developed a sophisticated system that travels with patients as they experience life and their symptoms. The concept came from Steve.
“Patients have most of their symptoms when they’re at home or work, not at the doctor’s office. Our system travels with patients as they experience life and their symptoms.”Anand Navalgund, PhD, Director of Clinical Science, G-Tech Medical
Steve: My mother died from colon cancer. My sister’s a survivor. Her daughters have GI issues and my daughter Lindsay has Crohn’s disease. This opportunity to work at G-Tech Medical became very personal.
Lindsay: As someone who lives with Crohn’s, I have more insight into things like usability or the patient’s perspective. When we design a study, I make that leap to the patient. It’s one thing to think you know how patients respond or what they want. But it’s another to be in that world. I want this to be successful for people like me.
Steve: We are hopeful that through routine monitoring we’ll see the signs that are leading to a flare and catch it early, instead of waiting and reacting, adjusting their drugs after the damage is done. Something truly proactive and convenient—you just wear the patch, carry your phone and the data shows up as a report for the physician.
“I have insight into the patient’s perspective. I want this to be successful for people like me.”Lindsay Axelrod, MTM, Staff Research Associate, G-Tech Medical
Lindsay: As a patient, if you start to feel not well, the last thing you want to think is that it’s your disease because that is a burden. You want to validate against it being your disease. Having a set time to wear these patches and see what’s going on, is easy to do. If the patch started to show changes and we understand what those changes mean to the underlying disease, you can be proactive and adjust medications earlier. Potentially, you’re less likely to have a more extreme flare exacerbated by the difficulty of getting timely care from your doctor. And it’s possible that the patch could illuminate correlations with other symptoms such as inflammation outside of the gut that more traditional IBD tests wouldn’t catch.
Initial Funding Seeded Key Breakthroughs
Anand: It’s vital for a thriving ecosystem of innovation to have organizations who fund the early science—mission driven organizations like the Rainin Foundation. They are the early believers in your technology. Investors are too skittish to fund hard science technology companies.
Steve: Three organizations have helped us enormously—we would not exist otherwise. The Rainin Foundation and Breakout Labs gave us our earliest funding. The Fogarty Institute gave our company a place to live and tremendous day-to-day support. Anand and I went the first two and a half years without any income. That was a very rough time. The Rainin Foundation’s first grant came through when we were very low on money. And then Breakout Labs gave us initial funding and the Foundation came through with more. It enabled us to make good progress in the data analysis code. That’s really the secret sauce. Other people could make a patch but the data analysis is the unique part.
Lindsay: I was one of your first test subjects 12 years ago. A breakthrough was seeing signals. We went from patients sitting in a chair with a whole array of electrodes on their abdomen to an actual patch and clinical correlations with those signals.
Steve: That’s true—our single biggest breakthrough was that test with the 30 electrodes on your belly and we could see the stomach signal.
Designing A Device For And With Patients
Anand: We discovered that it’s really hard to get something to stick on the abdomen, where you can go about your daily life for many days. People are often flexing, moving, contorting. Finding the right material and shape has been hard to solve. Our latest design is a material that’s super conformable, seamless and unobtrusive. It’s thinner and more breathable, and it’s water resistant.
Steve: The same thing with the electronics and the firmware and software. It’s just a long, painful slog of iterations to make it as perfect as we can and always thinking about how to make it easier for a patient to use successfully. We can’t tell patients to do it our way—we have to do it their way.
Anand: This system has gone leaps and bounds beyond the first-generation patch. We now have a much more sophisticated piece of technology, which runs for many more days than we had ever thought we would have. So it’s much, much closer to what we really want it to be. Yeah, that’s my thing.
Connections And Collaborations Lead To More Milestones
Steve: The Rainin Foundation’s impact has been more than funding. We met people and got exposure because of the Synergy grants. Kevin Grimes, who’s on the Foundation’s Scientific Advisory Board, introduced me to Aida Habtezion, a grantee at Stanford, at the Innovations Symposium. I was a speaker at another Symposium in 2018 and Jean-Frederic Colombel raised his hand to ask me a question. Now we’re working with him on an ulcerative colitis study. And because of those connections, we received a big grant from Helmsley Charitable Trust to do a Crohn’s study with Aida and Sid Sinha. Lindsay is working on the data analysis from that study and we’re getting excited about the difference in signals between a flare patient and a healthy control or a remission patient. That data is going to appeal to investors who might help with the $15 million we need for our next step.
Lindsay: The Stanford study is exploratory. We want to identify correlations between signals we see from our patch, and the gold standard lab tests or self-reported symptoms from patient surveys. And the data is revealing the kind of correlations we hoped to see among these three study groups. We also got FDA clearance in January and a CPT 3 code from the American Medical Association. Anand shepherded the second-generation design of the system and our FDA submission for 510(k) clearance.
Anand: Getting that FDA clearance is a big milestone because that tells the world that we have a technology that has been independently validated and is potentially useful. We were trying something with the patch that had not been done before. In addition to measuring gastric activity, which all our predecessors do, we are also measuring intestinal and colonic activity at the skin surface. Our challenge was to demonstrate that we measure what we say we measure, along with compliance to various safety standards.
Promising Clinical Studies
Lindsay: We’re also launching postoperative clinical studies. We’ve started at Yale and are in process with Harvard, Beth Israel and Mayo Clinic in Jacksonville. A lot more sites are in the early stages. As a small company, we do whatever it takes to support the study. Each of us pitches in to draft protocols to protect study participants, or field calls at 6 AM from the East Coast, or provide tech support with the app.
Anand: There’s a lot of excitement around the postoperative market. Typically, the recovery of the gut gets delayed after abdominal surgery. I remember vividly the experience with one of our first patients after a pancreaticoduodenectomy surgery, which affects the stomach and the duodenum. We put the patch on and saw no signal, no signal, and then suddenly a signal emerged. With more patients, we realized that the timing and amount of that signal indicated when and how patients were recovering. We are now replicating it across sites, different patient populations and different surgeries to get a better sense of that signal.
Steve: We’re also doing ambulatory studies with Brian Lacy at Mayo Clinic, Jacksonville and Jean-Fred Colombel at Mount Sinai. They’re both giants in the GI field. Jean-Fred is really excited. Years ago, he said that motility in the colon was an important parameter in ulcerative colitis and a better indicator for picking the right course of therapy. Other clinical measures don’t necessarily correlate well with patient symptoms—biopsies might indicate mucosal healing but that’s not what the patient experiences. We’re hoping to get funding for a longitudinal study with Jean-Fred and his team, and Yuying Luo, MD, a Gastroenterology Fellow at Mount Sinai Hospital. We’ll be comparing our technology alongside other clinical measures with patients who are in flare and go through a course of treatment.
“Our aspiration for our product is to be truly useful for patients: Help them understand their unique gut signal, where their underlying problem is, what’s benefited other patients and what will work for them.”Anand Navalgund, PhD, Director of Clinical Science, G-Tech Medical
Anand: With Brian Lacy at Mayo Clinic, we’re doing a comparison study against the gastric scintigraphy test for gastroparesis . In this test, patients eat radioactive eggs and sit in front of a gamma camera periodically over four to six hours. That test is considered the gold standard, but it uses specialized equipment and is only available at limited sites. It’s also not appropriate for everyone. We believe the G-Tech patch can meet the need for a noninvasive, reproducible, readily available test to assess gastric motility. And it has distinct additional advantages, as it records for multiple days and multiple, normal meals. So this study is huge for us.
Steve: We’ve also been talking with a large pharmaceutical company for some time about using our technology in a large study—500 to 1,000 patients—as an endpoint for one of their IBD drugs. They’re interested in using our system to directly measure the drug’s impact on a patient’s gut motility. They see its advantage over using patient questionnaires and indirect and inaccurate measures like patient-reported stool frequency.
A Message For The Field: Focus On The Patient
Lindsay: When I was younger, I went to the GI because you know your body and when you’re getting sick. He told me, “Well, you’re out of the hospital, you’re good.” I ended up getting into a flare and quickly dropped him as a doctor. Probably a lot of his dismissal was about not knowing what to do, or where to look. And this was a doctor at a well-known institution who does research and cares a lot about IBD.
Anand: A lot of the GI tests are negative tests—they tell you what you don’t have. That is frustrating for patients and clinicians because they don’t have a definite answer. We have a unique and incredible technology. We’re not there yet, but our aspiration for our product is to be truly useful for patients: Help them understand their unique gut signal, where their underlying problem is, what’s benefited other patients and what will work for them.
“Our research is entirely focused on patients. We need patients to participate. They’re contributing and they can walk away saying, ‘I did my little part.'”Steve Axelrod, PhD, President and CEO, G-Tech Medical
Lindsay: We’re trying to change the way healthcare is provided, which a lot of people are apprehensive about or not necessarily interested in. Asking people to wear this patch is completely different than any standard of care. We need people like Steve and Anand who truly care about making a difference and improving the way we treat patients.
Steve: Our research is entirely focused on patients. We need patients to participate in our studies. We need them to volunteer and we need them to consent. And, at this stage, they’re not getting any benefit from it. But they’re contributing and they can walk away saying, “I did my little part.”
The Foundation’s Commitment To Advancing IBD Research
In addition to grantmaking, the Rainin Foundation hosts an annual Innovations Symposium, which brings together researchers, trainees and clinicians to encourage dialogue and build bridges that enhance IBD research. Save the date for our 2023 Symposium, which will be held Monday, July 17 – Tuesday, July 18 at the Palace Hotel in San Francisco.
To learn more about the Rainin Foundation’s research grantees and funding areas, as well as its vision and strategy for solving IBD, visit: krfoundation.org/ibd.