Gut health is not the most glamorous of topics, but as many as 1 in 10 people regularly suffer from gastric symptoms like nausea, bloating, or cramping after eating. Without invasive tests, figuring out exactly what's causing stomach misery is not easy. But New Zealand-based startup Alimetry has developed a wearable device that can speed up diagnosis of functional gastric issues.

A noninvasive wearable consists of a flexible electrode array applied to the stomach of a patient, enabling it to capture electrical activity generated by the patient's gut. Analysis on a cloud environment and the use of artificial intelligence to extract signals from digestive noise work in capturing data, using it to turn it into useful clinical biomarkers that can be used to aid in patient diagnosis.

Less than a year after its first payment, the startup just raised a second tranche of Series A funding — $18 million, led by VC firm GD1 — on top of roughly $10 million it pulled in through an earlier Series A raise in 2021. It also raised seed funding back in 2019 the year it was founded.

The listen to your gut strategy
"It's quite like the heart; the gut runs on a natural electricity, and that electricity causes it to move," Dr. Greg O'Grady explained to me about his co-founding startup. "Those electrical rhythms and currents are really weak. They're about 100 times weaker than the heart, which makes them really difficult to detect.".

"People have known about them for a long time, but no one's been able to get at it reliably for clinical use — unlike the heart, which is obviously very mature and a huge industry now — and so the secret to cracking it has been taking a really high-resolution approach.". And it's only really been recently, through advances in stretchable electronics, in wearables, and in AI, that we're really cracking the code to make it possible.

One goes to an Alimetry clinic where the device is placed and a benchmark recording taken of their gut activity. A light meal is consumed in situ still wearing the device, and data captured as the stomach works. The patient logs in their symptoms using Alimetry's app during the test.

The time taken to complete the whole session-from benchmarking and active gut recording-is several hours. Then, the device is withdrawn from the body and Alimetry analyzes this information to transmit it to their doctor as a downloadable report to support diagnosis.

According to O'Grady, the data it presents can ensure clinicians know which phenotypes-or descriptive categories-apply to the condition of their patient so that treatment can be personalized.

One of the main things we can do-for example, something unique to what we do-is diagnose whether a patient has a true gastric neuromuscular disorder or not, and completely noninvasively, he tells TechCrunch, saying this is a major advance for diagnostics of functional gastric complaints.

This startup is using a "very high density" array of 64 electrodes to "turn the volume up" on its capacity to catch stomach activity. The array itself is a single-use device but another component of Alimetry's product-the reader-can be cleaned and reused after each patient use.

Alimetry sells hardware to the hospital. At this point, it doesn't have any software or licensing fees on top of that, but its continued development of the product and additional features may change things.

FDA approvals
Alimetry has been conducting pilots of its "gastric alimetry" wearable with over 30 hospitals in the U.S. market, the U.K., and New Zealand for a number of years. It's also received four clearances from the U.S. Food and Drug Administration, to use the device as a diagnostic aid; the company will apply for additional approvals as it continues to develop the product.

The startup believes that its technology could be applied to other areas as an adjunct for diagnostics in pediatrics, but problems with the colon; its first product is about stomach complaints. "It's a brand new class of technologies, and we've been developing it really fast," O'Grady says, adding: "As we discover new features, we put them through the FDA as soon as possible, then make them into the product. And we're definitely not done."

That, he says, "has greatly improved its ability to tease out useful signal from gastric noise."

We had a huge number of algorithms that would filter and process and analyze that data and present it to the clinician, and it only became possible once we'd done that a few thousand times that we could use the AI, he says. "And it's dramatically impressive how superior [it is] — we thought our algorithms were already excellent, but it's really been, you know, almost surprising how dramatically superior they are at eliminating noise through that training process. But it required a very large dataset [before we could train neural networks]."

The version of the product with AI will be sent for approval to FDA next quarter, O'Grady said.

Building utility
Meanwhile, while Alimetry's wearable may well be a boon for diagnosis of functional gastric disorders, such as chronic nausea, O'Grady confirms this noninvasive "body surface gastric mapping" approach is not going to chivvy some gut health issue down to its source. However, it could still help doctors narrow the list of potential causes of stomach complaints.

"We don't have all the answers in that category," he says. "For example, we do not pick up things such as the microbiome and influences that can cause an immune reaction and so on. And so there's always going to be a range of patients who require other testing."

That's the way it is with the gut, he adds. It's a pretty complex system, but we know that there's a very large number of patients within that functional group whom we can significantly help.

Does O'Grady envisage Alimetry's wearable technology enabling auto-diagnosis of pertinent health complaints in the future? He reckons it will be possible — although such a product would require a likely higher-risk class of regulatory approval. For now, the device firmly sits in the clinician support category with human doctors in the loop.

This funding will go to the next stage of commercialization as it looks to leverage a controlled market launch initiated in 2022 by getting more hospitals regularly utilizing its kit to aid in the diagnosis of neuromuscular gut disorders, sensory disorders, and gut-brain disorders.

"We're opening ourselves up to more hospitals," he says, emphasizing that increased availability will still come gradually, rather than in a big bang. "We are pretty intimate with the hospitals to ensure that the reimbursement billing is successful, and it doesn't come without a lot of work right now. And once those barriers begin to come down, then we will be spreading out — but we've got a reimbursement code that came through in July, a CPT III code, that is specific to this device, and it's going well."

The U.S. market will be the focus of the company's efforts as it moves down its commercialization path, O'Grady said. To date, Alimetry has approximately 4,000 tests on file — but the medtech will be seeking to come out much further ahead than that in the years ahead.

Dr. Bu' Hayee, Professor of Gastroenterology, King's College London said commenting on the device in a supporting statement; "It will transform how we approach patients with various gastric disorders; it is difficult not to get over-excited about this.".

Other investors participating in Alimetry's A2 funding round include the American Gastroenterological Association investment fund, AGA Ventures, as well as Icehouse Ventures and Olympus Innovation Ventures, along with follow-on from existing investors.