NeurAxis wins expanded FDA clearance for non-implanted neurostim for pain relief

NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve stimulator.

IB-Stim delivers nerve stimulation for functional abdominal pain relief. The new indication expands the system’s addressable market and overall devices per patient, according to a news release.

NeurAxis’ system utilizes its proprietary percutaneous electrical nerve field stimulation (PENFS) technology. It has FDA clearance for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents between 8-21 years old. The non-surgical device delivers gentle electrical impulses to cranial nerve bundles in the ear.

According to the company, no FDA-approved drug therapies exist for children with abdominal pain-related disorders of the gut-brain interaction. NeurAxis says pharmacologic treatments that use drugs off-label can lead to serious side effects. Additionally, the company says most of those therapies lack scientific evidence of efficacy.

Sign up for Blog Updates