The human gut, which includes the stomach, small intestine, and colon, is complex. It has its own nervous system, which is second only to the brain in its intricacy and explains why it doesn’t take much – strong emotions, travel, an unusual meal – to throw off the delicate balance of eating, absorbing nutrients, and eliminating waste. When the disturbance is temporary, there is little cause for concern. But when the problem is chronic, the impact can be life-altering, limiting one’s ability to eat normally, socialize with friends, or hold a job.
With multiple organs involved, but the same handful symptoms (diarrhea, constipation, bloating, nausea, pain), diagnosing the specifics of a digestive problem is equally complex. This is where G-Tech Medical’s patch comes in. The Fogarty company-in-residence has developed an “EKG for the Gut™,” a thin, wearable patch that collects detailed information about the functioning of the digestive system by reading the electrical signals from the gut for a period of up to six days. The data is transferred by Bluetooth to the user’s phone then uploaded to the cloud and processed by G-Tech, which shares the findings with clinicians.
The G-Tech patch is FDA-cleared, has its own CPT3 code for reimbursement, and just recently became commercially available.
Diagnostic dilemmas
“If you have gut pain, the cause may be any one of a number of problems, including cancer, a blockage, a fistula, or a leaky gut, among other options,” said G-Tech co-founder and CEO Steve Axelrod, PhD. “If you do a CT scan, you can detect cancer, and if you do a colonoscopy, you may find polyps. But most people don’t have problems that are anatomically obvious — for them, a visualization test comes back perfectly normal.” According to Axelrod, most people with issues have a functional problem, or what is called a disorder of the gut-brain interaction (DGBI). “It means that everything looks fine, but isn’t working correctly,” he said.
To provide physicians with better, more actionable information, the G-Tech patch has multiple capabilities that exceed currently available diagnostic tests. “For starters, we are able to monitor the entire gut, while currently available techniques measure function only in one organ at a time,” he said. “In addition, while other tests require unusual measures such as emptying the gut or inserting foreign objects and then being monitored in the doctor’s office, our patch monitors gut function under normal conditions at home, and for as long as six days.”
This enhanced information makes it possible to narrow in on the specific problem and area. “Our system provides information about what is happening in each part of the GI tract to help physicians understand not only what the problem is, but where it is, empowering them to treat it with appropriate medication or other therapies.”
Advancing the science
G-Tech’s comprehensive data collection has led to new insights about the workings of the GI tract. “For example, we have published data that shows that the colon has most of its activity at night. This is contrary to what was previously believed,” said Axelrod. “And we’ve shown that a lack of that nighttime activity correlates with patients who have constipation.” The finding is so intriguing that the G-Tech team is currently working with researchers at the University of Michigan on a study examining nighttime colon activity in constipated patients.
In another recent paper with Dr. Brian Lacy, an industry luminary who practices at the Mayo Clinic in Jacksonville, G-Tech showed that many patients suspected to have gastroparesis, meaning the stomach doesn’t have enough activity and is emptying too slowly, may actually have either normal or high activity in the stomach that just “isn’t well coordinated,” said Axelrod.
In the study, the G-Tech patch actually outperformed scintigraphy, the gold standard test for diagnosis and evaluation of GI motility issues. Scintigraphy measures gastric emptying by requiring the patient to eat radioactive eggs and then stand in front of a special camera over a four-hour period. “Scintigraphy identified three of 22 patients (close to the typical 20%) as having abnormal gastric emptying. The G-Tech patch identified 80% of the patients as having either very low activity (13) or very high activity, (5)” said Axelrod. “It’s the difference between measuring for four hours and measuring for six days,” he said. G-Tech has now published seven peer-reviewed publications with several more on the way.
Commercialization
Currently, G-Tech is busy raising a $10 million Series B round of funding and establishing a commercial presence. “Our first step is to get approval from the Value-Analysis Committees at hospitals, and we are also reaching out to some of the larger GI physician groups,” Axelrod said. “Once physicians see that payment is available, we believe they’re going to say, ‘Why wouldn’t I use this?’ Patients love the patch because it’s easy and you don’t have to get through five other tests and then eat radioactive eggs. You can just wear patches as a simple, non-invasive, and affordable first option.”