Media Release: Atmo Biosciences reaches 60 per cent recruitment target in dysmotility pivotal clinical study
• 85 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.
MELBOURNE, AUSTRALIA & SAN DIEGO, USA, 4 October 2023:
Atmo Biosciences, a company commercializing the world’s first ingestible gas-sensing capsule that provides insights into gut health and microbiome function, today announced it has commenced a pivotal clinical study to assess the use of the 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 U.S. and Australia have now simultaneously ingested the Atmo Gas Capsule and predicate device SmartPill to test the ability of Atmo’s gas-sensing capsule to assess whole and regional gut transit.
Clinicians evaluate 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). These disorders 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].
The results from the study will be used to support a 510(k) submission to the U.S. Food and Drug Administration (FDA) to obtain marketing clearance around the use of the Atmo device to assess gastrointestinal motility disorders.
Atmo Biosciences CEO Malcolm Hebblewhite commented: “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 U.S. 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.”
Co-Principal Investigator Dr. Braden Kuo, Director of the Center for Neurointestinal Health at Massachusetts General Hospital and Associate Professor at Harvard Medical School, added: “If the capsule is validated for measuring transit time, and subsequently cleared by the FDA, it will be a great tool to help gastroenterologists diagnose motility disorders such as gastroparesis and slow transit constipation.”
About Atmo Biosciences:
Atmo Biosciences is an Australian 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 as it travels through the gut. Atmo aims to improve the diagnosis of common 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.
1. Camilleri M, Kuo B, Nguyen L, Vaughn V, Petrey J, Greer K, et al. ACG Clinical Guideline: Gastroparesis. The American Journal of Gastroenterology. 2022;117(8):1197-220.
The Atmo Gas Capsule System is pending FDA 510(k) clearance and is not available for sale. The Atmo Gas Capsule System is an investigational device exclusively for use in clinical research.
