“This study demonstrates that Vibrant’s unique drug-free mechanism of action significantly improves patients’ overall constipation symptoms and quality of life,” said Rio Benchu, CEO, full of energy. “Vibrant provides healthcare providers with a new tool to expand treatment options for chronic constipation and may offer health systems and insurers a cost-effective solution to chronic constipation.”
Phase 3 trials evaluated the safety and efficacy of the Vibrant System in 312 CIC patients at more than 90 clinical centers in the United States, including Harvard Medical School, Augusta UniversityGeorgia Health Sciences University, University of Michiganand Houston Methodist Hospital.
Highlights from Phase 3 data
- The trial met all primary endpoints of weekly complete spontaneous bowel movements (CSBMs) with significant improvement in secondary outcomes compared with placebo.
- Compared to baseline, 39.26% of patients receiving the Vibrant System had one or more additional CSBMs per week compared to 22.15% in the placebo group (p<0.0001).
- Compared to baseline, 22.7% of patients receiving the Vibrant System had two or more additional CSBMs per week compared to 11.41% in the placebo group (p<0.0006).
- Data showed significant improvements in secondary outcomes compared with placebo in stool consistency (p<0.001), quality of life (p=0.0020), and exertion (p<0.0139).
- No serious adverse events or treatment-related diarrhea or nausea were recorded.
“Vibrant’s goal is to address a significant unresolved treatment problem in chronic constipation, which makes life very challenging for people living with constipation. We believe Vibrant is a meaningful step toward achieving this goal. ,”Say Satish RaoMD, MD, professor of medicine, one of the principal investigators.
Vibrant’s drug-free mechanism of action is based on the scientific understanding that the circadian rhythm, also known as the “biological clock”, plays an important role in our biological digestion. People are more prone to constipation when their biological clocks are out of sync. Vibrant’s technology resynchronizes the circadian clock through mechanical stimulation of the colon, potentially harnessing the gut-brain connection to improve bowel movements, relieve constipation symptoms and improve quality of life.
“Furthermore, with our innovations in gastroenterology, we have the opportunity to help millions of CIC patients gain access to new drug-free treatments that offer predictable, affordable and effective options to manage them frequent and bothersome symptoms,” shared Kathryn CollisVibrant’s CCO.
Based on Phase 3 results, Vibrant has submitted its system to the U.S. Food and Drug Administration for approval.
Vibrant is a pioneer in the treatment of chronic idiopathic constipation (CIC) with a unique mechanism of action based on the scientific understanding that people are more prone to constipation when their biological clocks are out of sync.
Drug-free disposable capsules for oral administration are guided by a capsule that activates and sends operating instructions to the capsule. Once ingested, the capsules resynchronize the circadian clock through mechanical stimulation of the colon, thereby improving bowel movements, relieving constipation symptoms and improving quality of life.
The treatment’s companion app helps patients self-track their treatment progress, helping to achieve better health.
Vibrant capsules are a research device and are for research use only U.S.. It is currently under FDA review and cannot be sold.
To learn more about Vibrant, visit www.vibrantgastro.com.
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