February 8, 2024.
The Atmo Gas Capsule has been safely ingested more than 1,000 times during formal, ethics-approved clinical studies.
The patients who have ingested the gas-sensing capsule during 13 clinical trials in which Atmo is involved have included healthy individuals, patients with suspected dysmotility, patients with suspected IBS, patients with suspected SIBO, and patients testing the effects of dietary interventions.
There have been no serious device-related adverse events during any of these ingestions.
Atmo Biosciences’ Head of Clinical Affairs and Co-Founder Kyle Berean said the 1,000 ingestion milestone was evidence of Atmo’s commitment to its clinical program.
“Starting with 41 ingestions of the capsule in 2019, these numbers have grown steadily each year, with 341 ingestions in 2023. Along the way, Atmo and our clinical partners have been collecting valuable data about how the human gut functions, providing insight into our first clinical indication related to motility and multiple other gastrointestinal disorders,” Dr. Berean said.
“The Atmo team has also been using insights from the ingestions to improve the capsule’s performance and manufacturability. This is truly cutting-edge technology and I would like to thank our clinical partners, patients, supporters and the Atmo team who helped us get to this point.”
The Atmo Gas Capsule is currently an investigational device exclusively for use in clinical investigations and is not available for sale.