Israeli-based device developer Vibrant Gastro initially submitted for FDA 510(k) clearance and won FDA De Novo classification on Aug. 26, Chief Marketing Officer Ben Feldman said today.
The drug-free capsule is indicated for adults with chronic idiopathic constipation who have not experienced relief despite using laxative therapies for at least one month. The new device will be available in select U.S. states early next year, with gradual national expansion throughout 2023.
How the Vibrant pill treats constipationVibrant Gastro says its technology is built on the premise that our circadian rhythm — commonly referred to as our “biological clock” — plays an important role in our digestive process. The Vibrant pill’s mechanical vibration of the colon can synchronize an out-of-sync patient and improve bowel movements.
To start the treatment, a patient with a prescription places the Vibrant capsule in the accompanying multi-use activation pod device to activate the capsule, then swallows the capsule with a glass of water. The capsule passively makes its way through the digestive system to the colon, where it vibrates to mechanically stimulate the colon and resynchronize the biological clock to improve daily bowel movement bio-rhythm.
The system includes enough disposable, single-use capsules for a month’s use and a treatment-tracking app. Patients may start to see results with one to eight weeks.
Vibrant Gastro submitted pivotal clinical trial results for 312 chronic idiopathic constipation patients to the FDA for its review of Vibrant. In that study, patients using the Vibrant capsule had at least one additional bowel movement per week, the company said:
“The pivotal trial’s outcomes demonstrated superiority with respect to both the proportion of patients with at least 1 additional complete spontaneous bowel movement per week compared to baseline, 40.51% in the treatment arm, compared to 22.92% in the control arm, a difference of 17.6% (chi-square p-value = 0.0011) and at least 2 additional complete bowel movements per week, 23.42% in the treatment arm, compared to 11.81% in the control arm, a difference of 10.0%.”
Vibrant Gastro said there were no significant adverse events in patients who used the Vibrant capsule.
The treatment is for chronic constipation, defined as fewer than three bowel movements per week, with symptoms persisting for weeks or months.
What’s next for Vibrant GastroVibrant Gastro aims “to accelerate the transition to drug-free treatments that enable millions of constipation patients to live more enjoyable lives by inventing solutions that synchronize and activate the body’s natural gut-brain connection,” Vibrant Gastro CEO Lior Ben-Tsur said in a news release, adding that the company plans to seek an expansion of indications.
“Millions of chronic idiopathic constipation patients continue to use laxatives chronically with little to no relief of their recurring symptoms,” Ben-Tsur said. “Vibrant provides the sufferers with an additional treatment option that is effective, safe and drug-free.”
Vibrant Gastro said its Synchronized Activation Method system will offer opportunities to develop data-driven personalized treatments and additional indications leveraging the gut-brain connection via the Enteric Nervous System pathway.
Vibrant Gastro’s U.S. operations are headquartered in Newton, Massachusetts.