A Better Kind of “Gut Check”

Often referred to as the “second brain,” the gut is garnering increased attention as mounting evidence shows the key role it plays far beyond digesting food in influencing our moods and general health. G-Tech Medical, a Fogarty Institute company, is playing a critical role in helping to better understand the complexities of our gut and its 500 million neurons.

With its innovative GutCheck Patch, a thin, flexible, comfortable patch worn on the skin, the startup is tracking the electrical signals that naturally occur in the digestive tract — also called the gastrointestinal or GI tract — due to muscle contractions of the stomach and intestine, and is studying their patterns in individuals following abdominal surgery.

“The gut has its own nervous system, which gives it the complexity needed to digest the food we eat,” said Steve Axelrod, Ph.D., CEO of G-Tech Medical. “But its intricacy also means that much can go wrong. For a patient with GI issues, while everything may look fine in a colonoscopy or CT scan, there are often underlying functional issues that stump physicians. At present these are very difficult to measure, especially non-invasively. We are gathering data that will help build a comprehensive picture of what’s going on in the human gut with the goal of improving patient care.”

Studies provide important data

G-Tech is currently enrolling patients in three new clinical trials in addition to the three studies that have been underway for more than two years at El Camino Hospital, the Parkinson’s Institute and Clinical Center and different divisions at the Stanford University Medical Center.

The first new study is at Lucile Packard Hospital, where they are examining children recovering from surgery. “The patients we are working with include kids from age 15 down to a preemie who weighed only 1.5 kilograms,” Steve said, adding that this is a particularly exciting trial for them.

“We are seeing very good, clear signals from all their organs, which is so important for children, especially younger ones who aren’t able to communicate. With our system, we are able to see the muscular contraction of each organ, giving us an unprecedented view inside to how everything is functioning post-surgery. That will open new doors and provide the knowledge physicians need to provide better care.”

G-Tech is also working on a second gastroesophageal reflux disease (GERD) study with the same Lucile Packard team.

The third study, which will be underway shortly, will focus on individuals suffering from gastroparesis, a condition affecting more than 1.5 million people in the U.S., which prevents the stomach from properly emptying.

Currently, the most common way to diagnose gastroparesis is a nuclear medicine test where individuals eat a meal, generally an egg, that contains a small amount of radioactive material, which is tracked for several hours through the digestive process. However, this method is lengthy and has not proved to be very accurate. By comparison, G-Tech’s system measures how the stomach works after eating a meal and can distinguish the difference between types of foods eaten based on the degree and duration of stomach muscle activity. Patients can wear the patches in the comfort of their own home and eat any meal prescribed by the physician, who will be able to determine if the stomach is working normally or if it needs to be stimulated.

Presenting results to peers

The success of its ongoing trials have generated strong data that was presented at the annual Digestive Disease Week Conference, which was held in Washington D.C. earlier in June. The G-Tech team, composed of Steve; Anand Navalgund, Ph.D.; and Steve’s daughter Lindsay Axelrod, who has been working at the startup for the past two years following a stint as Fogarty Institute intern, presented three scientific posters from these trials.

The El Camino Hospital study has shown that the G-Tech system can predict on the second day after surgery when the patient will pass their first flatus, with an error of less than a day. This is no trivial matter, because it provides a personalized schedule that tells health practitioners when the patient can begin eating post-surgery, thus allowing them to leave the hospital faster.

In addition, the startup presented data that showed excellent reproducibility of the measurement, sensitivity of the measurement to stimulant medications, and ability to detect the difference between types of meals, as described above.

The team is also in the process of writing journal articles for submission, including one to the American Journal of Physiology on patients recovering from pancreatic cancer at Stanford Hospital and another on patients recovering from open abdominal surgery at El Camino Hospital. These articles will describe the strong correlation between the system’s ability to detect signals on the second day after surgery and ability to predict when the patient can have their first meal.

Preparing to expand for potential uses

Next for G-Tech is to go back to the Institutional Review Boards to show the data and receive approval on their next steps. The first goal is to provide the data to the surgeon and hospital staff to determine the most effective schedule for each patient’s feeding and hospital discharge, with the aim to improve outcomes and shorten hospital stays.

“There are so many applications for our technology,” said Steve. “This is a very exciting time for the company as we are pulling together the data from the results of our longer-term studies and getting those results published, while simultaneously starting these new clinical trials. We are beginning to see concrete results from our data, which has been very well received and is generating a lot of interest among physicians.”

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