• Primary endpoints reached in a multi-site pivotal clinical trial. • Data will support a regulatory submission with the FDA in Q2 CY2024 for an initial indication in gastrointestinal motility disorders. MELBOURNE, AUSTRALIA & SAN DIEGO, USA, 10 April 2024: Atmo Biosciences, a company commercializing the world’s first ingestible gas-sensing capsule that provides insights into gut health, is delighted to report that it has successfully reached its primary endpoints in a pivotal clinical study to assess whole and regional gut transit time in subjects with suspected gastrointestinal motility disorders. More than 200 subjects from 12 trial sites in the U.S. and Australia ingested the...

• Pivotal clinical study data published in Clinical Gastroenterology and Hepatology. View the published study here. • All study endpoints were achieved, with findings presented recently at major U.S. and European gastroenterology conferences. • Data will support a U.S. FDA regulatory submission for an initial indication to evaluate whole and regional gut transit to assess common gastrointestinal motility disorders. MELBOURNE, AUSTRALIA & SAN DIEGO, USA, 4 March 2025: Atmo Biosciences, the innovator behind the ingestible gas-sensing capsule for gut health, today announced the publication of pivotal clinical study data in Clinical Gastroenterology and Hepatology. The study validates the Atmo Capsule for assessing whole and...

• Atmo secures full ownership of core IP for its ingestible gas-sensing capsule • RMIT University transfers all patents and IP in exchange for an equity stake in Atmo • Agreement enhances Atmo’s strong IP position ahead of regulatory milestones MELBOURNE, AUSTRALIA & SAN DIEGO, USA, 15 April 2025: Atmo Biosciences, a leader in ingestible gas-sensing technology, today announced the successful assignment of its foundational patent portfolio from RMIT University. Under this agreement, RMIT has transferred all patents and associated intellectual property (IP) related to the Atmo Gas Capsule to Atmo Biosciences in exchange for an equity stake in the company. This IP was...

• US FDA 510(k) regulatory clearance enables Atmo Biosciences to market and sell its ingestible gas-sensing capsule in the USA • Clearance is for an initial indication to aid diagnosis of gut motility disorders such as gastroparesis & slow transit constipation • FDA clearance was supported by data from a multi-site, pivotal clinical study of the capsule which met all endpoints MELBOURNE, AUSTRALIA & SAN DIEGO, USA, 27 June 2025: Atmo Biosciences, a leader in ingestible capsule technology, is delighted to announce that it has received US Food and Drug Administration (FDA) 510(k) clearance for the Atmo Gas Capsule System, paving the way for...