Spotlight Series: Tracking the inner workings of your gut
Every year, Breakout Labs hosts Unboxing — our annual showcase in which Breakout Labs portfolio companies “unbox” their scientific innovation. Because the world looks very different this year and we cannot gather our wonderful community for this special event, we’ve decided to showcase our companies, and their most recent achievements, with our new Spotlight Series. Today, we’re shining the light on G-Tech Medical.
G-Tech Medical is developing a non-invasive medical patch system that functions like an EKG for the gut: the system takes electrical measurements of the stomach and intestines to understand how the gut works under non-artificial conditions and translates that data to help physicians better treat patients who may be suffering from gastrointestinal (GI) disorders or recovering from abdominal surgery. The G-Tech system consists of wireless, wearable electrode patches that read electrical signals at the skin surface, a smartphone app that collects the raw data from the patches via bluetooth, and data-analysis algorithms that process and quantify the motor activity of the digestive organs. G-Tech’s Patch System is focused on meeting market-driven and clinical needs to create a new standard of care that both dramatically improves outcomes and reduces costs associated with GI conditions. The inexpensive, accurate, and easy to use real-time ability to assess activity of the GI organs provides the potential to transform care for patients, providers and institutions.
Breakout Labs funded G-Tech back in 2014 because of their unique approach to addressing GI motility dysfunctions and disorders. With the funding, the company was able to develop the first iteration of their wireless patch system. From there, the company has gone on to achieve so much more, including collecting data from over 500 patients, partnering with Stanford for their biggest study yet on Crohn’s disease, and their recent Series A raise, led by DigiTx Partners. We sat down with G-Tech’s CEO Steve Axelrod to learn more.
Breakout Labs (BOL): Steve — Let’s dive right in. You have a super interesting background. Can you tell us more about your progression from hardware and sensor development to medical device consultant to startup founder?
Steve: I can sum up my background by the term I sometimes use (with tongue in cheek) to describe my field — gastrophysics. Yes, I may be the only gastrophysicist you’ve ever heard of. I started my career in elementary particle physics, working at the big accelerator labs like Brookhaven and SLAC, smashing quarks and searching for fundamental truths of how the universe is put together. I came to the Bay Area to do a postdoc at Stanford, and fell in love with the west coast. I took a job developing complex measurement devices for industrial measurements — things like nuclear and X-ray sensors, data acquisition systems, and large scanning frames. It was intellectually challenging, but making products for the paper, plastics and foil industries didn’t do much for me at an emotional level. Then I got an opportunity to switch to the medical device field. It meant going back to being an individual contributor rather than Director of a large group but the opportunity to work on a new treatment for breast cancer made it well worth the trade-off. After five years or so, I wound up fascinated by how to measure and make sense of the tiny electrical signals at the skin surface coming from the gastrointestinal tract. Hence, G-Tech.
BOL: Gastrointestinal (GI) motility is a very specific function to target. What drove you to explore solutions for measuring motor activity of the digestive tract?
Steve: This venture is a great fit for my background in that for my whole career I’ve been setting up experiments that involve precise and/or difficult measurements, then processing and searching the data for underlying signals, and finally trying to understand what those measured signals tell us about nature. Instead of using physics experiments to understand how the universe is put together, which admittedly is very cool, we’re using our electrical measurements of the stomach and intestines to understand how the gut works under non-invasive, non-artificial conditions and translating that information to help physicians help their patients who might be suffering from IBS, or IBD, or recovering from abdominal surgery. No quarks are smashed or harmed in these studies (chuckles).
The more significant thing that brings me to this venture is the fact that serious GI issues run in my family. My mother died of colon cancer, my sister is a survivor, and my youngest daughter Lindsay has Crohn’s Disease. In the summer of 2007, she spent five weeks in the hospital when she should have been on the softball field and preparing for eighth grade. My wife and I traded off being with her in the hospital. It was the most frightening thing I have ever lived through, watching her lose so much weight and blood until they finally found an effective treatment. I have a lot of empathy now when I hear of someone who has a child that is seriously ill. Going through that experience gave me the focus and drive to make G-Tech succeed.
BOL: I’m sorry to hear your family has gone through such a harrowing experience. I understand that you’re not only helping those with Crohn’s Disease. What other disorders are associated with GI motility?
Steve: We like to distinguish between disorders, things like Inflammatory Bowel Disease (Crohn’s and colitis), Irritable Bowel Syndrome and similar functional GI issues in ambulatory patients, and the more transient dysfunctions such as the temporary shut down of the gut following abdominal surgery. All of these are intimately linked to motility and can be addressed by our technology, and the markets for the two categories are quite different. The hospital recovery market is large, with many millions of abdominal surgeries each year, but the ambulatory market represents around ten or fifteen percent of the population. It affects people worldwide: there are roughly a billion people with GI issues.
BOL: Tell us more about how your wearable patch system works.
Steve: The patches, typically three of them, are simply placed on the abdomen, like a smart bandaid. They’re held on by adhesive and don’t penetrate the skin. They each have four sets of measuring electrodes which sense the tiny electrical currents that are given off by the stomach and intestines when they are busy mixing or moving their contents — your last meal, or maybe the one before that — from point A (your mouth) to point B (the other end). It’s very analogous to an EKG of your heart, which measures the same type of electrical signals given off by the heart when it pumps. The difference is that the gut signals are much, much smaller and far less consistent, which makes them harder to measure and more complicated to sort out. The raw data from the patches is sent by Bluetooth to an iPhone or iPad touch, and then to a cloud server so it can be processed and analyzed. A report is then provided to the patient’s physician. The basic processing of the data is common to all use cases, with only the last part, the interpretation relative to the disease state, being unique.
BOL: Are you currently testing the system on patients?
Steve: We’re lucky that the system is so benign that we have been able to run studies on patients with only Institutional Review Board (IRB) approval. The FDA doesn’t get involved with anything that is deemed a non-significant risk. We’ve run well over 500 tests in a wide variety of studies on hospitalized and ambulatory patients. Our biggest active study is with Crohn’s Disease patients, where we’re partnering with Stanford on a trial supported by a generous grant from the Helmsley Charitable Trust. All together we’ve had 18 scientific conference posters, 3 invited talks and three journal articles published on our findings. Two more papers are currently in the review process with medical journals. These and future studies will guide us in learning how to best employ the results to help doctors treat their patients effectively and efficiently.
BOL: I know that you have a stellar team you’ve been working with on the technology. More specifically, your Principal Scientist Anand Navagund has been with you from the very beginning. How did the two of you get together to take G-Tech from idea to product?
Steve: Anand actually preceded me at G-Tech by a couple of months, back in 2011. He had just finished a short postdoc after his PhD in biomedical engineering at The Ohio State University, where he did some nice work on measuring electrical currents from skeletal muscles using similar techniques. He hadn’t worked at a company that made and sold products, much less a medical device company that has to deal with Regulatory, Reimbursement, and Quality processes. He’s now our go-to person on the Quality System and is preparing our upcoming FDA submission, as well as being deeply involved in all our clinical studies and data analysis. He’s very smart, super dedicated, and incredibly good to work with. You know, the usual small company, overachiever story.
Our third full time employee is none other than our poster “child,” Lindsay. She was an intern at the Fogarty Institute as an undergrad at UC Davis and then came to work for us when she graduated with a degree in biochemistry. She took a break after two years to get a Master’s in Translational Medicine in a wonderful program jointly run by UCSF and UC Berkeley, and is now back full time. She’s pretty smart herself (if a proud Dad can say so), and brings a powerful sense of the patients’ perspective to our everyday work.
BOL: You recently raised some capital — $3.5M first close on your Series A to be exact — congratulations! What are some of the milestones you hope to hit in the next year with G-tech Medical?
Steve: Thank you! The round is led by DigiTx Partners and we still have $2.5M open. With these funds, we’re focused primarily on two major tasks. The first is putting together an FDA submission using the 510k pathway, for use of the system as an adjunctive tool. It’s a first step on a path where we will continue to do the science and clinical work to prove usefulness of the system in various specific clinical indications like post-op recovery, IBD and so forth.
The second task is a complete redesign of our system, from patches, electronics and firmware through the back-end data analysis and report generation. We’ve already had a formal informational meeting with the FDA which went very well and we have a pre-submission meeting with them in late September. We have some top notch consultants helping us and we’re all very detail oriented and science-driven, so I’m feeling good about the upcoming submission. Similarly, the teams we’re working with on the patch redesign are people I’ve known for many years who have a lot of experience in skin-worn patches and Bluetooth communication from wearable devices. I’m excited by the potential for improved performance in the next generation system.
BOL: This is all great news, Steve. G-Tech has really come a long way. Is there anything else you’d like to add before we wrap up?
Steve: The work we do is really centered around patients; that’s the beauty of being in this field. I developed some pretty cool products 20 years ago, which are still being used today and, of which, I am proud, but it’s not even in the same league of emotional fulfillment or career satisfaction as the work we’re doing at G-Tech. I’m proud to work for a company that puts patients first.