FDA Awards New Clearance to NeurAxis’ IB-Stim

NeurAxis Inc. has picked up a new U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications for its IB-Stim Nonimplanted Nerve Stimulator for functional abdominal pain relief. The new indication expands IB-Stim’s addressable market and overall devices per patient.

“We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly 75%,” NeurAxis President/CEO Brian Carrico said. “Furthermore, we expect devices per patient to increase, as this new FDA clearance states on label use of four devices per patient. All of this has been achieved due to the strong body of published research, which has resulted in the increased acceptance of our PENFS technology. This includes ongoing expansion of payer coverage, as well as the recent establishment of a new CPT Category I code by the American Medical Association, effective January 2026. Our recent achievements in our commercialization strategy have set the stage for increased revenue and margin growth in the upcoming quarters.”

NeurAxis’ IB-Stim is cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 8-21 years old. IB-Stim is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction. Pharmacologic treatments that use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy.

NeurAxis Inc. is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive the adoption of its IB-Stim therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.