Posted: 14 December 2023
More than 200 patients recruited in multi-site clinical trial to support a submission for initial U.S. regulatory clearance around the use of Atmo’s gas-sensing capsule to assess gastrointestinal motility disorders.
Atmo Biosciences, a company commercializing the world’s first ingestible gas-sensing capsule that provides insights into gut health and microbiome function, has reached its recruitment target ahead of schedule for its dysmotility pivotal clinical study.
The multi-site comparative study is assessing the use of the Atmo Gas Capsule to measure gastrointestinal transit time in patients with suspected motility disorders by demonstrating equivalence to a predicate device, the SmartPill. Clinicians evaluate whole and regional gut transit to help diagnose motility disorders such as gastroparesis (delayed emptying from the stomach), and slow transit constipation (slow transit through the colon).
Starting in July 2023, the study took place at 11 clinical sites in the United States and 1 site in Australia. During the study, more than 200 patients ingested both the Atmo Gas Capsule and SmartPill in order to compare the two devices, then went about their lives while the capsules transmitted data as they travelled through the different regions of the gastrointestinal tract.
The results from the study will be used to support a 510(k) submission to the U.S. Food and Drug Administration (FDA) in 2024 to obtain marketing clearance around the use of the Atmo device to assess gastrointestinal motility disorders.
Professor William D. Chey, Co-Principal Investigator of the study and Chief of Gastroenterology and Hepatology at the University of Michigan, said: “We’re very pleased to have completed recruitment for the pivotal clinical study so quickly. We’re now looking forward to analyzing the data to determine the Atmo capsule’s safety and efficacy for measuring transit time in dysmotility patients.”
Dr. Michael Cline, site Principal Investigator at Cleveland Clinic, added: “Dysmotility disorders, such as gastroparesis and chronic constipation, affect many millions of people each year, with patients often experiencing debilitating symptoms such as nausea, vomiting, bloating, abdominal pain, and abnormal bowel habits[1]. These disorders are often difficult to diagnose due to overlapping symptoms. With the discontinuation of the SmartPill, there’s a demand for a comprehensive tool to measure overall gastrointestinal transit across regions. This is crucial to assess pan-dysmotility, enabling differential diagnosis and more targeted treatments. We’re excited by the potential of the Atmo Gas Capsule to fill that gap.”
Atmo Biosciences CEO Mal Hebblewhite commented: “We are delighted to have met our patient recruitment target ahead of schedule. It is a testament to the efforts of our 12 clinical partners who conducted the study at their institutions. This support from esteemed gastroenterologists gives me a lot of confidence as we prepare for a U.S. regulatory submission and subsequent market launch.”
The Atmo Gas Capsule is currently an investigational device exclusively for use in clinical investigations and is not available for sale in the USA.
