11:04 AM EDT, 05/20/2025 (MT Newswires) -- (Updates with the latest stock price movement in the headline and first paragraph.)
NeurAxis' (NRXS) shares climbed by more than 112% in recent Tuesday trading after the company said the US Food and Drug Administration granted clearance to expand the use of its IB-Stim device to treating functional abdominal pain linked to functional dyspepsia and nausea in patients aged 8 to 21.
The approval is the first FDA-cleared treatment for pediatric functional dyspepsia and builds on the device's prior clearance for irritable bowel syndrome, the company said.
NeurAxis said the expanded use nearly doubles IB-Stim's addressable market and will be launched using its existing reimbursement and provider network.
IB-Stim is a non-surgical device that uses neuromodulation to treat gut-brain interaction disorders, with no FDA-approved drug therapies currently available for these conditions in children, NeurAxis said.
Price: 4.95, Change: +2.68, Percent Change: +117.93