Trials – Atmo Biosciences

PIVOTAL STUDY

Dysmotility pivotal clinical study currently underway in the U.S. and Australia

In August 2023 Atmo 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).

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.

This 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.

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.

Institutions participating in the pivotal study include Houston Methodist, Hartford HealthCare and Cleveland Clinic.

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Over 120 subjects with functional gastrointestinal symptoms and dysmotility are being recruited at 12 sites in the United States and Australia.

PILOT TRIAL

Results show Atmo Gas Capsule can be used to assess whole gut transit times

A multicenter study, including 43 patients with suspected dysmotility ingested the Atmo capsule and SmartPill simultaneously and researchers compared the transit times of the two capsules through the different regions of the gastrointestinal tract.

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.

Results showed the two devices had similar transit times and diagnostic agreement, thereby validating the Atmo capsule relative to SmartPill for measurements of gastric emptying time and colonic transit time for patients with gastroparesis and chronic constipation.

The study follows a clinical trial demonstrating strong agreement between the Atmo Gas Capsule and SmartPill for measuring transit time in healthy subjects.The results showed that the Atmo Gas Capsule was readily ingested, well-tolerated and technically reliable.

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Gas concentrations in the gut are 5,000 to 10,000 times higher than those in the breath, which results in the Capsule’s superior signal to noise ratio when compared to breath testing.

The current method for measuring gas biomarkers is using breath tests. Breath tests, however, are an indirect measurement technique requiring the gases that are generated in the gut to be absorbed into the blood stream, circulated around the body, transferred into the lungs and finally exhaled out of the mouth. For this reason breath tests show low specificity and sensitivity when compared to the direct method used by the Atmo Gas Capsule.