- The FDA clearance is based on clinical study results assessing IB-Stim vs PBO in patients with functional abdominal pain associated with Irritable Bowel Syndrome (IBS) aged 11-18 yrs.
- The study results demonstrated 81% improvement in symptoms with no SAEs & minimal side effects. Additionally, it shows that 70% patients failed to improve with an average of four medications trialed, prior to IBM-Stim treatment
- The IB-Stim is a non-surgical device, works by sending electrical impulses into cranial nerve bundle in ear and targets brain areas associated with pain and aids in functional abdominal pain in IBS
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