Posted: 11 August 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.
The study involves simultaneous ingestion of the Atmo Gas Capsule and predicate device SmartPill to demonstrate 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).
About 120 subjects with functional gastrointestinal symptoms and dysmotility are expected to be recruited in the study at up to 13 sites in the United States and Australia. Initial subjects have been recruited in the U.S. at Hartford Health Neurogastroenterology and Motility Center, Connecticut, and in Australia at University of Western Sydney, Sydney.
The results from the study will be used to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) to obtain marketing clearance for the device in the U.S.
Atmo Biosciences CEO Malcolm Hebblewhite said the launch of the trial was an important milestone for Atmo.
“We are excited to commence recruitment of patients for this pivotal study to support our initial clinical indication, the evaluation of motility disorders. This is a crucial step for the business, and will be used to support our submission for regulatory clearance with the FDA in 2024, paving the way for product launch in the important USA market,” Mr. Hebblewhite said.
Professor William D. Chey, Co-Principal Investigator of the study and Chief of Gastroenterology and Hepatology at the University of Michigan, said: “We are excited to be evaluating Atmo against the SmartPill in measuring gastric emptying and colonic transit time through continuous measurement in dysmotility patients. Dysmotility disorders, such as gastroparesis and chronic constipation, affect many millions of people each year. Patients can experience chronic, debilitating symptoms such as nausea, vomiting, bloating, abdominal pain, and abnormal bowel habits1.”
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: “As many gastrointestinal disorders share similar symptoms, more diagnostic tools are needed to help clinicians pinpoint the problem. The Atmo capsule shows great potential as a diagnostic tool for motility disorders, and we are happy to have this trial underway to test its safety and efficacy.”
During the study, patients ingest both the Atmo capsule and SmartPill, then go about their lives while the capsules continuously record measures as they travel through the different regions of the gastrointestinal tract. While both devices assess transit time, SmartPill uses pH, temperature and pressure to identify when the pill moves through different gut regions, whereas the Atmo capsule uses a range of measures including hydrogen and carbon dioxide concentration, and temperature.
The pivotal study follows a series of pilot trials comparing transit measurements from the Atmo Capsule to SmartPill, including one trial in healthy subjects and one in patients with symptoms of gastrointestinal motility disorders. Both studies validated the Atmo capsule relative to the SmartPill for measuring transit time.
Dr. Vincent Ho, a clinical academic gastroenterologist at Western Sydney University, commented: “I am delighted to be involved in this study following my involvement in the successful Atmo dysmotility pilot trial, which has helped inform the pivotal study design. During both the pilot and now the pivotal trial, we have found patients to be very willing to embrace this technology to help diagnose their gastrointestinal problems.”
The Atmo Gas Capsule is currently an investigational device exclusively for use in clinical investigations and is not available for sale.
