- 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, Sydney, San Diego – 10th 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 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.
About Atmo Biosciences:
Atmo Biosciences is a digital health business commercializing the world’s first ingestible, gas-sensing capsule which provides insight into gut health and microbiome function. Atmo’s gas-sensing capsule continuously measures clinically important gaseous biomarkers and other data as it travels through the gut. With 40% of the world’s population suffering from gastrointestinal conditions, Atmo aims to improve the diagnosis of common and often debilitating functional gut disorders, leading to more personalized treatments and earlier relief of symptoms for sufferers. The gas-sensing capsule is currently being used in research applications in multiple clinical trials around the world. www.atmobiosciences.com
