• US FDA 510(k) regulatory clearance enables Atmo Biosciences to market and sell its ingestible gas-sensing capsule in the USA
• Clearance is for an initial indication to aid diagnosis of gut motility disorders such as gastroparesis & slow transit constipation
• FDA clearance was supported by data from a multi-site, pivotal clinical study of the capsule which met all endpoints

MELBOURNE, AUSTRALIA & SAN DIEGO, USA, 27 June 2025:

Atmo Biosciences, a leader in ingestible capsule technology, is delighted to announce that it has received US Food and Drug Administration (FDA) 510(k) clearance for the Atmo Gas Capsule System, paving the way for its first product to be marketed and sold in the USA.

This breakthrough milestone is another significant step in Atmo’s commercial execution plan to bring the product to a wider audience of healthcare providers and patients globally.

The Atmo Gas Capsule offers clinicians a convenient solution for assessing both whole and regional gut transit times—covering the stomach, small bowel, and colon—to aid in diagnosing gastrointestinal motility disorders. These include gastroparesis (delayed emptying from the stomach) and slow transit constipation, both of which are treatable conditions. By measuring regional and whole gut transit, the capsule eliminates the need for more cumbersome procedures such as gastric scintigraphy or radio-opaque marker studies, and avoids exposing patients to radiation. During the Atmo test, patients can go about their normal daily activities.

Motility disorders affect millions of individuals worldwide, causing debilitating symptoms like nausea, vomiting, bloating, abdominal pain, and abnormal bowel habits. The FDA clearance enables Atmo to address a large unmet clinical need in diagnosing these conditions, which can remain undiagnosed or misdiagnosed for years.

The FDA’s decision was based on a pivotal clinical study in which 209 subjects across 12 sites (11 in the U.S. and 1 in Australia) ingested both the Atmo Gas Capsule and a predicate device (SmartPill). The study met all endpoints, demonstrating the Atmo Gas Capsule’s equivalence in assessing gastric emptying time and colonic transit time.

“We are thrilled to have achieved FDA clearance for this important initial indication in motility,” said Mal Hebblewhite, CEO & President of Atmo Biosciences. “The Atmo Gas Capsule is a much-needed test that gives clinicians comprehensive, clinically valuable information so they can diagnose and manage patients quickly, conveniently, and accurately.”

The Atmo Gas Capsule System will be available commercially in the USA from July 2025.

ABOUT ATMO BIOSCIENCES

Atmo Biosciences is a medical device and digital health business commercializing ingestible capsule technology. Atmo’s first product is an ingestible, gas-sensing capsule that provides insight into gut health. Atmo’s gas-sensing capsule measures whole and regional gut transit times to aid gastroenterologists in diagnosing gut motility disorders. Atmo strives to improve the quality of life for the many sufferers of common and debilitating gastrointestinal disorders and diseases, providing clinicians and researchers with tools that deliver actionable insights regarding gastrointestinal dysfunction. The gas-sensing capsule is currently being used in research applications in multiple clinical trials around the world.

FOR MORE INFORMATION

Malcolm (Mal) Hebblewhite
CEO & President
Atmo Biosciences
Cell: +1 (619) 459 2600
Mob: +61 418 465 728
E: mal.h@atmobiosciences.com