Atmo Biosciences reaches primary endpoints in pivotal clinical study for initial indication

April 9, 2024.

Atmo Biosciences 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 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 (emptying from the stomach) and colonic transit time (transit time in the large bowel) to assist with diagnosis of gastroparesis and slow transit constipation. 

The results from the comparative study will support a 510(k) submission in Q2 of CY2024 to the U.S. Food and Drug Administration (FDA) seeking regulatory clearance in an initial indication for the use of the Atmo device to assess gastrointestinal motility disorders. 

Atmo Biosciences CEO Mal Hebblewhite commented: “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.” 

The Atmo Gas Capsule is currently an investigational device exclusively for use in clinical investigations and is not available for sale in the USA.