Atmo Biosciences, a company commercialising the world’s first ingestible gas-sensing capsule that provides insights into gut health, has reached its primary endpoints in a pivotal clinical study to assess whole and regional gut transit time in subjects with suspected gastrointestinal motility disorders.
The company said more than 200 subjects from 12 trial sites in the US and Australia ingested its 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.
The company said the study results would support a 510(k) submission in the second quarter of calendar year 2024 to the US FDA seeking regulatory clearance in an initial indication for the use of its device to assess gastrointestinal motility disorders.
Atmo Biosciences CEO Mal Hebblewhite said, “We are thrilled to have reached the pivotal study’s primary endpoints. This result gives us confidence as we complete our current capital raise, prepare a U.S. regulatory submission, and plan for subsequent market launch, pending FDA clearance.”