Atmo Biosciences - Ingestible Capsule Set To Revolutionise Gut Health Diagnosis
Pictured: Atmo CEO Malcolm Hebblewhite said the BioMedTech Horizons project enabled the Atmo team to take its first steps towards identifying a large target group of patients living with SIBO globally.
Many individuals worldwide suffer from gastrointestinal (GI) disorders, which incur debilitating symptoms, significant morbidity and high healthcare costs.
Irritable bowel syndrome (IBS), for example, affects 25 to 45 million people in the US and two to five million people in Australia1,2. Other common disorders include motility abnormalities, small intestinal bacterial overgrowth (SIBO), which is often associated with IBS, and inflammatory bowel disease (IBD).
Yet such conditions often remain undiagnosed and untreated. Gases are important biomarkers of disease, dysfunction and dysbiosis, but current diagnostic methods for GI disorders are normally highly invasive or rely on subjective symptomatology and questionnaires. Diagnostic methods such as aspiration, biopsy, endoscopy, motility pills, imaging pills and breath testing all have limitations. Even with these limitations, the current SIBO diagnostics market is growing rapidly with increased awareness and is estimated to reach US$194 million in 20283.
Gas sensing from within the gut offers an accurate method for diagnosing common GI conditions, but to date there have been no convenient tools available to clinicians.
Creating an accurate, cost-effective and user-friendly diagnostic solution
Seeking to create an accurate, cost-effective and user-friendly diagnostic solution for common GI disorders, Melbourne-based biotech company Atmo Biosciences is developing the world’s first single-use, ingestible motility and gas-sensing capsule. While previous ingestible pills had been developed and are useful for motility assessment only, they do not offer the same breadth of measurement and diagnostic capability as the Atmo Biosciences solution.
The capsule, when swallowed, can electronically report important data about the human GI system by detecting gases in real time from known locations within the gut. Clinicians can use these biomarkers to diagnose conditions such as SIBO, and consequently provide targeted treatment to patients – which, in turn, leads to earlier relief of symptoms and reduced healthcare costs.
The Atmo capsule leverages technology initially licensed from RMIT University in 2018 and has been in development since. Measurement of motility in transit was the first test case and that product was substantially developed but still under clinical trial when they received BioMedTech Horizons (BMTH) funding in 2020 through BMTH Round 3. With this new funding Atmo set out to demonstrate proof of concept for its gas[1]sensing technology to be incorporated into the same capsule, and to develop algorithms to correlate gas composition measured from the capsule to gut health issues, including IBS and SIBO.
Atmo’s goals were to scale up the manufacturing process to ensure production of capsules for testing purposes; evaluate and select a diagnosis method; develop machine learning and artificial intelligence (AI) tools; analyse signals from the capsule; and run a clinical study to assess the diagnostic method.
Atmo completed the planned clinical studies validating gas sensing in the capsule during transit through the gut with IBS with more than 120 capsules administered. The team benchmarked its diagnostic criterion against the two existing diagnostic methods: hydrogen breath testing and the gold-standard jejunal aspirate. The pilot-study results showed a good correlation to the latter, while emphasising the poor outcomes offered by breath testing.
Pictured: The Atmo Biosciences single-use gas-sensing capsule up close.
Accelerating the development of technology over a short time frame
According to Atmo CEO, Malcolm Hebblewhite, the BMTH project enabled the team to take its first steps towards identifying a large target group of patients living with SIBO globally.
“This evidence helps to strengthen our investment thesis to target conditions with unmet clinical needs such as GI motility disorders and SIBO,” he said. “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, which facilitated the establishment of an international medical advisory committee.”
Atmo scaled up manufacturing from 150 capsules per year to 500, to support the needs of the subsequent testing and validation studies and achieved ISO 13485 accreditation at its facility in Melbourne to ensure it could manufacture the product for clinical use. This produced flow-on benefits to other aspects of company activities, including the ability to engage with functional food companies to investigate gut gas composition upon change in diet.
In May 2022, Atmo received additional BMTH funding through the fourth round of the program with the aim to have all technical requirements in place to initiate the final clinical validation – a pivotal trial – in preparation for regulatory approval and market launch.
This project resulted in the successful completion of product verification and significant progress towards regulatory and commercial readiness. Key achievements included IEC 60601 certification for electrical safety, ISO 10993 certification for biocompatibility, along with the preparation of a Human Factors Summative Evaluation Protocol. Hardware readiness was also achieved, and the final labelling and packaging were designed, critical achievements in commercialising a medical device.
Multi-site pivotal study to support US FDA submission
Atmo commenced participant recruitment in a multi-site pivotal study which will support an initial US Food and Drug Administration (FDA) submission around the use of the Atmo Gas Capsule to assess GI transit, which is relevant to the assessment of motility disorders such as gastroparesis and slow transit constipation.
Pictured: Atmo Biosciences - a biotech company based in Melbourne, Victoria - was funded twice within the BMTH program.
Through the two projects, the company significantly strengthened its intellectual property (IP) position to support its commercial plan. One provisional patent moved to PCT stage, and three more provisional patent applications were lodged. The European Patent Office and IP Australia granted key patents that will provide coverage until 2037. The US Patent and Trademark Office also granted a patent for Atmo’s ingestible gas-sensor capsule.
Hebblewhite said: “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 US is particularly satisfying, as it supports our commercial plans, which prioritise this large and important market.”
Data generated from the BMTH-supported activities has supported Atmo to significantly advance its commercial goals, including raising $9.6 million in private capital and raising $8 million in a fully subscribed Series B funding round.
Successful completion of the project activities has taken Atmo several steps closer to market entry, said Atmo’s Head of Clinical Affairs, Dr Kyle Berean.
Taking crucial steps forward to realise key goals
“It has been an incredible journey from our initial research on the underlying capsule technology to these final stages of product development,” he said. “During this project, we have taken many crucial steps forward towards realising our goals of addressing unmet clinical needs and improving quality of life for many patients suffering from common gut disorders.”
Atmo’s Head of Commercial, Sue Dafnias, said support from the BMTH program has been critical in achieving several key milestones in the final verification, validation and commercialisation of the Atmo Gas Capsule.
“The successful completion of this project has facilitated product readiness for our pivotal study, which will ultimately support an initial FDA 510(k) regulatory submission to aid the diagnosis of gastroparesis and slow transit constipation,” she said. “These are both debilitating gastrointestinal motility disorders impacting millions of individuals worldwide.
1. International Foundation for Gastrointestinal Disorders, ‘IBS Facts and Statistics’
2. Dietitians Australia, Irritable Bowel Syndrome
3. Global Small Intestinal Bacterial Overgrowth Diagnostics Market Report 2021