Australian company Atmo Biosciences has announced the publication of pivotal clinical study data in Clinical Gastroenterology and Hepatology.
The company is developing an ingestible gas-sensing capsule for gut health.
The company said the study validates the Atmo Capsule for assessing whole and regional gastrointestinal transit times to assist with the diagnosis of highly prevalent motility disorders such as gastroparesis and slow transit constipation.
It said the results would support a 510(k) submission to the US FDA seeking regulatory clearance in an initial indication for the use of the Atmo Capsule to assess gastrointestinal motility disorders.
More than 200 subjects from 12 trial sites in the US and Australia ingested the Atmo Gas Capsule and a predicate device, the Wireless Motility Capsule, to test the comparative ability of Atmo to assess the primary endpoints of gastric emptying time and colonic transit time to assist with diagnosis of gastroparesis and slow transit constipation.
All study endpoints were met. The findings were presented at significant gastroenterology conferences in late 2024, including the United European Gastroenterology Week, the American College of Gastroenterology, and the Federation of Neurogastroenterology and Motility Meeting.
Principal investigator Dr Braden Kuo of Massachusetts General Hospital said, “The comparative study data shows that the Atmo Gas Capsule correlated well with the other technology on assessments of gastric emptying time and colonic transit time. These results demonstrate that the Atmo Capsule is a clinically useful method for evaluating gastrointestinal transit.”
Atmo CEO Mal Hebblewhite said, " The publication of our pivotal clinical study data is a significant milestone for Atmo, marking the culmination of years of R&D, clinical collaboration, and a steadfast commitment to transforming patient care. We are thrilled to share these findings with the global medical community, bringing us one step closer to making the technology available to clinicians to improve outcomes for those who need it most."