BMTH: Ingestible Capsule Set To Revolutionise Gut Health Diagnosis
Pictured above: The Atmo Gas Capsule aims to play a critical role in diagnosing – and improving – gut health.
Sophisticated gas-sensing technology is paving the way for better understanding of gut health – in the hope of giving clinicians a world-first tool to aid diagnosis and manage debilitating gastrointestinal disorders.
Gut disorders impact tens of millions of people globally, yet many go untreated, as conclusive diagnostic tests remain elusive. A new platform developed by Atmo Biosciences is aiming to provide an accurate, cost-effective, and user-friendly diagnostic solution.
Small intestinal bacterial overgrowth (SIBO) is one such disorder that is difficult to diagnose. SIBO occurs when excess bacteria in the small intestine ferment undigested food, generating hydrogen as a by-product. SIBO is thought to be associated with a range of uncomfortable symptoms, including bloating and gas. If left untreated, SIBO can lead to serious complications like inflammation, autoimmune disease, nutrient deficiencies and malnutrition.
Currently, the prevalence of SIBO is unclear, mainly due to the lack of reliable diagnostic tools. Diagnoses are further complicated by the absence of universally accepted diagnostic parameters, and significant overlap with symptoms of other gastrointestinal (GI) disorders, such as irritable bowel syndrome (IBS) and functional dyspepsia. Without conclusive diagnoses, clinicians often trial antibiotics for symptom relief, which contributes to issues of over-prescription and the spread of antibiotic resistance.
An unmet medical need for an accurate and repeatable diagnostic test
With SIBO suspected to be signficantly underdiagnosed in the general population, there is an unmet medical need for an accurate and readily repeatable diagnostic test.
Digital health company Atmo Biosciences is working to address this issue by developing the Atmo Gas Capsule System*: a world-first gas-sensing capsule that, when swallowed, travels through the gut and detects gases in real time from known GI locations. Clinicians hope to use these biomarkers to diagnose conditions such as SIBO, and consequently provide targeted treatment to patients.
The Atmo Gas Capsule was invented at RMIT University in Melbourne, Australia. In 2018, Atmo Biosciences signed a licencing deal with RMIT, securing the exclusive worldwide rights to commercialise the capsule. The capsule inventors are continuing to lead research and development at Atmo, together with a dedicated team of Atmo engineers.
BMTH funding and support helps demonstrate proof-of-concept
Supported by funding from MTPConnect’s BioMedTech Horizons (BMTH) program, in 2020 Atmo Biosciences set out to demonstrate proof-of-concept for its gas-sensing technology. The team benchmarked its diagnostic criterion against the two existing diagnostic methods: hydrogen breath testing and the gold-standard jejunal aspirate. The preliminary pilot results showed a good correlation to the latter, while emphasising the poor outcomes offered by breath testing. While the outcome measures were strong, additional work is required to validate the diagnostic method in a diverse population.
Future work will leverage the diagnostic criterion created during the BMTH project and focus on the development of an algorithm for SIBO diagnosis using the Atmo Gas Capsule. Additional clinical data will also be obtained to build the managed dataset that is required for the next phases of algorithm development. Further data will likewise be collected to demonstrate the clinical utility of the technology in monitoring patient outcomes, and its impact on treatment decisions.
First steps towards identifying a large target group living with SIBO globally
According to Atmo Biosciences CEO, Malcolm Hebblewhite, the BMTH project has enabled the team to take its first steps towards identifying a large target group of patients living with SIBO globally.
“This initial evidence helps to strengthen our investment thesis to target conditions with unmet clinical needs such as GI motility disorders and SIBO,” said Mr Hebblewhite. “This program has allowed us to accelerate the development of our technology in a short period of time. The project has also increased our engagement with global key opinion leaders and clinicians,” he said.
Given that SIBO is associated with many conditions, including IBS, the Atmo Gas Capsule represents a high-value commercial opportunity. The market for SIBO diagnostics was valued at US$138 million in 2020 and is projected to reach US$194 million by 20281.
The BMTH project has helped Atmo confirm a clinical application with significant investment potential, and accelerated Atmo Biosciences’ progress towards accessing this market.
Exciting milestones – $9.56 million capital raise and US patent granted
In September 2021, Atmo Biosciences raised $9.56 million, led by two new investors – Sydney-based investment firm Alium Capital Management and Japanese multinational company Otsuka Pharmaceutical Co.
In mid-September 2022, Atmo Biosciences announced that the US Patent and Trademark Office (USPTO) had granted the patent for Atmo’s ingestible gas sensor capsule. The granted patent protects the ingestible capsule’s unique gas-sensing functionality and the ability to wirelessly transmit the data it collects.
Mr Hebblewhite said: “The grant of this patent is an exciting milestone for Atmo Biosciences. The patent is an important cornerstone of Atmo’s IP strategy for protection of the Atmo Gas Capsule System and the Atmo future product pipeline.
“Grant of the patent in the USA is particularly satisfying, as it supports our commercial plans, which prioritise this large and important market,” he said.
Published study showed capsule’s usefulness and will lead to clinical trial
Earlier this month, Atmo Biosciences announced the publication of a clinical study supporting the Atmo Gas Capsule’s ability to determine its location in the gastrointestinal tract. The study demonstrates strong agreement between data from Atmo’s Gas Capsule and a validated, FDA-cleared Wireless Motility Capsule (WMC), in determining transit metrics in healthy subjects. Based on this data, Atmo intends to conduct a clinical trial in patients with gastrointestinal motility disorders. The study was published in the journal Alimentary Pharmacology & Therapeutics.
Recent data released by the American Gastroenterological Association showed that nearly 40 per cent of Americans have stopped routine activities such as doing exercise or running errands in the last year due to uncomfortable bowel symptoms2. Measurements of gut motility are important for evaluating and diagnosing these patients.
Professor Peter Gibson, Head of Luminal Gastroenterology Research at the Central Clinical School, Monash University commented: “Results from this recent study are particularly pleasing in that they demonstrate such strong agreement between Atmo’s gas-sensing capsule and WMC. The gas-sensing capsule is able to provide useful data to determine if a person’s gut motility is too fast or slow. This personalised information is likely to be key for future clinical practice as different gastrointestinal disorders require different interventions.”
Mr Hebblewhite said: “Data from this study has provided us with the confidence to progress to a study involving patients who suffer from the motility disorders that we are aiming to diagnose. We are very excited to be working with key opinion leading gastroenterologists who specialise in functional gut disorders to support the upcoming study.”
Gas-sensing capsule aims to play a critical role in diagnosing gut health
Once developed, the Atmo Gas Capsule aims to play a critical role in diagnosing – and improving – gut health. By enhancing the efficiency and accuracy of diagnoses, it may simplify the diagnostic journey for millions of individuals suffering from SIBO, mitigating the need for repeated medical appointments and offering substantial longer-term benefits for the healthcare system, both here in Australia and worldwide.
Other long-term benefits include the potential to limit the unnecessary use of antibiotics – thereby preventing indiscriminate harm to the gut microbiota of patients – while also decreasing the financial burden experienced by SIBO sufferers and enhancing their quality of life.
To learn more: Atmo Biosciences
*The Atmo Gas Capsule is currently an investigational device exclusively for use in clinical investigations and is not available for sale.
Footnotes:
1. Global SIBO Diagnostics Market Report 2021-2028
2. ‘New survey finds forty percent of American’s daily lives are disrupted by digestive troubles” – American Gastroenterological Association press release, 14 September 2022; www.gastro.org/news