Atmo Biosciences reaches 60 per cent recruitment target in dysmotility pivotal clinical study
October 3, 2023.
Atmo Biosciences has reached 60 per cent of its recruitment target for 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.
The results from the study will be used to support a 510(k) application 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 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.”
The Atmo Gas Capsule is currently an investigational device exclusively for use in clinical investigations and is not available for sale.
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.