Atmo Biosciences, which is commercialising an ingestible gas-sensing capsule that provides insights into gut health and microbiome function, has announced it has reached 60 per cent of its recruitment target for a pivotal clinical study.
The study is assessing the use of the company's Atmo Gas Capsule to measure gastrointestinal transit time in patients with suspected motility disorders.
More than 85 patients from 10 different trial sites in the US and Australia have now simultaneously ingested the Atmo Gas Capsule and predicate device SmartPill to test its ability to assess whole and regional gut transit.
The company said results from the study will be used to support a 510(k) submission to the US FDA.
CEO Malcolm Hebblewhite said, “We are very pleased to have recruited more than half of the patients planned for the dysmotility trial so quickly. With 10 sites actively recruiting participants and a final site due to come on board soon, we are on track to complete enrolment this calendar year. That puts Atmo Biosciences in a great position to be able to make a submission for US regulatory clearance in 2024.”
Professor William D. Chey, Co-Principal Investigator of the study and Chief of Gastroenterology and Hepatology at the University of Michigan, said, “The pivotal clinical trial is progressing very well, with patient recruitment on track. We look forward to analyzing the data to determine if the Atmo capsule is comparable to the FDA-registered SmartPill device for assessing transit time.”