By Omar Ford
Measuring the behavior of the GI tract to pinpoint disorders can be a difficult task for physicians. While there are numerous tests that physicians can apply during a routine visit, many of these tests are unable to actually capture measurements while the GI system is at work.
G-Tech Medical (Palo Alto, California) has a remedy for this and has developed a wireless, wearable "ECG for the gut" that senses muscle activity from the GI tract over several days and relays data to a smartphone and on to a cloud server. The company said that the data will transform physicians' ability to determine underlying causes of functional GI disorders and the effectiveness of treatments.
"The idea is that people wear these patches for a few days," Steve Axelrod, president/CEO of G-Tech, told Medical Device Daily. "They're thin and light, comfortable and conforming, you can go about your daily life. That's very important for a GI diagnostic. When you're not doing normal things your GI system doesn't behave normally. If you go to the doctor and have a test done, your GI system shuts down."
G-Tech's device uses traditional wired ECG style hardware, essentially 3 ECG systems in parallel, with 30 electrodes in a grid across the abdomen. The company digitizes and records raw data from each of the 18 sense electrodes for later analysis by a custom LabVIEW-based application. G-Tech has developed algorithms that identify the instances of rhythmic electrical activity associated with mixing and propulsion of the luminal contents of the stomach, small intestine and colon.
Data algorithms will create each person's unique internal GI signature based on their responses to specific meals, medications and patterns leading to and during symptoms (pain, cramps, nausea, bloating).
Axelrod said that the patches could lead to greater insight regarding patients than standard measurements being used today.
"You can't do a 20 minute measurement and learn very much about the GI system because it's a 24-hour cycle," he said. "We call it an ECG for the gut. When you measure the heart with an ECG for one second you've got a heartbeat, in 10 seconds you have some pretty decent data. Our target is a patch that will last for three days. The doctors will put the patches on you and say we're going to learn about the function of your GI system. Physicians using the system should be able to give you a profile of the performance of your digestive system. The physicians can go from there and target the therapies that work best for you."
FDA approval could be a little more than two years away for the device.
"I have a 650 task-project-plan that gets us to product release in 38 months," he told MDD. "We'll do a clinical trial with the second prototype. That's the version before the final manufacturing prototype. With the second prototype we'll do maybe a thousand person clinical trial and with that, we'll collect the data that we need for the FDA and to show insurance companies that this works and is going to be cost effective and save money."
The firm said that clearance could should be pretty standard since the device wasn't making a diagnosis of the disease.
"We believe that FDA clearance should be pretty straightforward," he said. "This is a patch that you wear on your body. It's strictly non-invasive and we're going to let the doctors do the actual diagnosis. We will present them with data, on how active a person's stomach, small intestine or colon is . . . and let them be the ones to make judgment on the diagnosis. That will make the FDA pathway for us much easier."
G-Tech was one of several companies to recently receive funding from Breakout Labs (San Francisco), a nonprofit fund that supports scientific innovation. Medical Device Daily reported on EpiBone (New York), another company that garnered funding from Breakout Labs in Monday's issue (Medical Device Daily, June 16, 2014). Breakout Labs also provided funding for Cortexyme, a firm developing therapeutics that could alter the course of Alzheimer's and other disorders of aging.