Gut health isn't the most glamorous topic, but as many as 1 in 10 people regularly suffer from stomach symptoms such as nausea, bloating, and cramps after meals. Determining the exact cause of your stomach upset is not easy without invasive tests. But New Zealand-based startup Alimetry has developed a wearable device that can speed up the diagnosis of functional problems in the stomach.
This non-invasive wearable consists of a flexible electrode array that is applied to a patient's stomach and can detect electrical activity occurring in the stomach. Cloud-based analysis, including the use of artificial intelligence to extract signals from digestive noise, transforms the collected data into useful clinical biomarkers that support patient diagnosis.
The startup just secured its second tranche of Series A funding led by VC firm GD1, on top of the approximately $10 million raised in previous A funding in 2021. It also raised seed funding in 2019. Established.
listen to your gut
“It's a lot like the heart. Your intestines run on natural electricity, and that electricity moves your intestines,” explains co-founder and CEO Dr. Greg O'Grady. “Their electrical rhythms and currents are very weak. They are about 100 times weaker than the heart, so they are very difficult to detect.
“People have known about it for a long time, but no one has been able to reliably bring it to clinical use. It's different from the heart. The heart is obviously very mature and , it's now a huge industry. So it took us a while to figure out the secrets of it.'' It's a really high-resolution approach. And it's only recently, with advances in stretchable electronics, wearables, and AI, that we've actually been able to crack the code that makes this possible. ”
To use the device, patients visit a clinic where Alimetry's device is applied and benchmark recordings of bowel activity are taken. The device will remain in place while you consume a snack, allowing it to collect data as your stomach functions. Patients also record any symptoms they experience during the test in Alimetry's app.
The entire session (from benchmarking to active bowel recording) lasts several hours, after which the device is removed and data analysis by Alimetry is sent to the doctor as a downloadable report to support diagnosis.
O'Grady says this data can help clinicians determine which phenotypes (or descriptive categories) apply to a patient's condition and personalize treatment.
“For example, one of the main things we can do, which is unique to our work, is the ability to completely non-invasively diagnose whether a patient has a true gastric neuromuscular disorder.” he told TechCrunch. This is a major advance in the diagnosis of functional gastric diseases.
The startup uses an “ultra-dense” array of 64 electrodes to increase its ability to capture stomach activity. While the array itself is a disposable device, another component of the Alimetry product (the reader) can be cleaned and reused after each patient use.
Alimetry's business model involves selling hardware to hospitals. At this time, there are no additional software or license fees, but that may change as we continue to develop the product and add features.
FDA approval
For several years, Alimetry has been testing its wearable “gastric nutrition meter” in more than 30 hospitals in the U.S. market, the U.K., and New Zealand. The company has also received four permits from the U.S. Food and Drug Administration to use the device as a diagnostic aid. The company plans to apply for more approvals as the product continues to evolve.
The company believes its technology could be further used to support pediatric diagnostics and the diagnosis of problems affecting the colon. But its first product focuses on stomach upset. “This is a completely new kind of technology, and we've been developing it very rapidly,” O'Grady said, adding: “When we discover new features, we submit them to the FDA and incorporate them into our products as quickly as possible. And we're not done yet.”
He says the (recent) addition of AI-based data processing has greatly enhanced the ability to extract useful signals from stomach noise.
“We had a huge number of algorithms to filter, process, and analyze data to present it to clinicians, but only after we had done it thousands of times could we use AI,” he says. . “And it's dramatically impressive how good it is.” [it is] — I thought our algorithm was already good, but it's almost surprising how dramatically better it is at removing noise through the training process. But that required a very large dataset [before we could train neural networks]”
A version of the product that incorporates AI is expected to be submitted to the FDA for approval in the next quarter, O'Grady said.
architectural utilities
While Alimetry's wearables could help diagnose functional gastric disorders such as chronic nausea, O'Grady said this non-invasive “surface stomach mapping” approach could help diagnose the causes of all types of gastric disorders. He admits that it doesn't help with tracking. Gut health issues. But it may still help your doctor narrow down the list of potential causes of your stomach upset.
“We don't have all the answers within that category,” he says. “It doesn't pick up things that might affect things like the microbiome or immune response, for example. So there will always be patients who need other tests.”
“That's the way the gut is,” he added. “It's a pretty complex system, but we know there are a huge number of patients within that functional group that we can help significantly.”
Asked whether Alimetry's wearable technology could automate the diagnosis of related health complaints in the future, O'Grady said he believes it is possible, but that such a product (perhaps in a high-risk class) ) would require regulatory approval. For now, the device is firmly placed in the clinician-supported category, with human doctors also involved.
The startup's Series A2 funding will support a managed project launched in 2022 to get more hospitals into regular use of kits that support the diagnosis of neuromuscular gastrointestinal disorders, sensory disorders, and gastrointestinal diseases. The company aims to further enhance its market release and will be used in the next stage of commercialization. Brain disorders.
“We are opening up more hospitals,” he said, stressing that expanding access would be gradual rather than a big bang. “We are working closely with hospitals to ensure reimbursement, but that requires significant effort at the moment. And once those barriers start to come down, we will continue to expand But we've got a unique redemption code for this device, a CPT III code, which was issued in July, and that's on track.”
O'Grady said the company's main focus as it continues its commercialization journey remains the U.S. market. So far, Alimetry has logged around 4,000 tests, but medical technologists hope to build on this by targeting even more patients in the coming years.
Dr. Bu Heiyi, professor of gastroenterology at King's College London, commented on the device in a statement of support, saying that wearables are “changing the way we approach patients with a range of gastric diseases.” , added: I'm excited about this. ”
Other investors in Alimetry's A2 funding round are AGA Ventures (Foundation of the American College of Gastroenterology), IceHouse Ventures, and Olympus Innovation Ventures, followed by existing investors.