NeurAxis Announces FDA Clearance for IB-Stim Label Expansion to Pediatric Functional Dyspepsia, Nearly Doubling Its Total Addressable Market

Life Sciences

NeurAxis, Inc.

Published on

May 21, 2025

KAREN STERLING, PhD, CFA

First Treatment Ever Cleared by the FDA Related toFunctional Dyspepsia; Sales Team Will Leverage Existing Reimbursement and Provider Infrastructure; Reiterate Buy Rating

Shares of NeurAxis, Inc. (NRXS), a growth-stage medical technology company developing neuromodulation therapies to address chronic and debilitating conditions in children and adults, gained 76% yesterday after the company received FDA510(k) clearance for its IB-Stim device for Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia (indigestion) and Functional Dyspepsia-related Nausea Symptoms. The clearance covers patients 8-21 years of age and is the first treatment ever cleared by the FDA related to functional dyspepsia.

The label expansion – IB Stim was already cleared for Functional Abdominal Pain associated with Irritable Bowel Syndrome in patients aged 8-21 years - is thought to nearly double the company’s pediatric addressable market. The company’s sales team will be targeting the same base of pediatric gastroenterologists for the new indication, leveraging the same CPT code and insurance coverage. Commercial rollout for the new indication will begin immediately, and in light of the fact that NeurAxis will be using the same provider call points as for the existing IBS indication, we expect a seamless and capital-efficient launch process.

Publication of academic society guidelines recommending IB-Stim as standard of care and first-linetherapy for pediatric functional abdominal pain (FAP) remains NeurAxis’s next milestone, expected bythe end of May 2025. In addition to the Category I CPT code going into effect on January 1, 2026, we expect these guidelines to function as a significant catalyst for broader insurance coverage, facilitating treatment access for the majority of affected children in the U.S.

Given the earlier than expected FDA label expansion, we have increased our revenue forecast for the second half of 2025, from $2.25 million to $2.75 million, and from $8 to $11 million for FY 2026. We reiterate our Buy rating on the stock.