NeurAxis Receives Historic FDA Clearance for IB-Stim to Treat Pediatric Functional Dyspepsia and Associated Nausea

May 20, 2025

DENVER, Colo., May 20, 2025 (247marketnews.com)- NeurAxis (NYSE:NRXS) announced that it received FDA 510(k) clearance for its IB-Stim device for the treatment of Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia (FD) and FD-related nausea in patients aged 8 to 21 years.

This clearance marks the first-ever FDA authorization for a treatment specifically targeting functional dyspepsia, a common yet under-treated gastrointestinal disorder in the pediatric population. It also represents the second expanded FDA indication for IB-Stim, following its initial clearance for FAP associated with Irritable Bowel Syndrome (IBS).

Brian Carrico, President and CEO of NeurAxis, commented, “This latest FDA clearance represents a pivotal milestone in NeurAxis’ growth strategy. Expanding into the treatment of Pediatric Functional Dyspepsia pain that includes related nausea symptoms, not only broadens our clinical impact but also positions us to drive significant revenue growth through a capital-efficient rollout. This progress is fueled by a robust body of clinical evidence supporting our PENFS technology, which continues to gain traction among providers and payers. Notably, we are seeing expanded insurance coverage and, most recently, the American Medical Association’s approval of a new CPT Category I code for IB-Stim, which will take effect in January 2026.”

Expanded Indication, Seamless Market Integration

The new FD indication is expected to nearly double IB-Stim’s total addressable market, significantly expanding NeurAxis’ commercial footprint. Importantly, the new indication utilizes the same CPT code, insurance coverage, and provider network as the existing IBS indication, enabling a capital-efficient and rapid commercial rollout, which begins immediately.

IB-Stim: A Non-Invasive Option Where No FDA-Approved Drugs Exist

IB-Stim is a non-surgical, non-pharmacologic neuromodulation device that delivers gentle electrical impulses to cranial nerve bundles in the ear to help regulate gut-brain interaction. The device is currently the only FDA-cleared treatment for pediatric abdominal pain disorders of gut-brain interaction (DGBIs), such as IBS and now functional dyspepsia.

There are currently no FDA-approved drug therapies for children with these disorders. Off-label pharmacologic treatments often carry serious side effects and typically lack strong clinical evidence, underscoring the importance of a safe, effective alternative like IB-Stim.

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