Breakthrough for Young Lives: FDA Greenlights First-Ever Treatment for Debilitating Pediatric Gut Disorder

Landmark Approval: NeurAxis secures historic FDA clearance for IB-Stim™ to treat Pediatric Functional Dyspepsia (FD) and related nausea, a condition previously without approved therapies^{1, 2, 3}.
Hope for Young Sufferers: The non-invasive device offers a lifeline to children aged 8-21 battling severe abdominal pain, nausea, and associated issues like fear of eating and weight loss^{1, 3}.
Rapid Relief on the Horizon: Commercial rollout begins immediately, poised to nearly double NeurAxis' market reach with a capital-efficient strategy¹.

CARMEL, Ind. – A new dawn breaks for thousands of children tormented by the relentless pain and nausea of Functional Dyspepsia (FD). NeurAxis, Inc. (NYSE American: NRXS) today announced a monumental victory: FDA 510(k) clearance for IB-Stim™ to treat Pediatric FAP associated with FD and its debilitating nausea symptoms in patients aged 8 to 21 years¹. This isn't just another approval; it's the first-ever FDA-cleared or approved treatment for this specific gut-brain disorder in young patients, shattering a long-standing barrier in pediatric care^{1, 2}.

For too long, children have faced a grim landscape with no FDA-approved drug therapies, often resorting to off-label medications with potential serious side effects and scant evidence of efficacy^{1, 6}. IB-Stim™, a non-surgical device delivering gentle electrical impulses to cranial nerves via the ear, changes everything. "Functional dyspepsia can cause severe abdominal pain and nausea... often lead[ing] to serious secondary issues," explained Dr. Adrian Miranda, Chief Medical Officer of NeurAxis. "We are thrilled by the agency’s decision, which gives us the opportunity to offer real hope to thousands of patients and their families who have had limited options—until now"¹.

This pivotal clearance, building on IB-Stim's earlier success with IBS-related pain, leverages existing insurance coverage and will be further bolstered by a new CPT Category I code effective January 2026^{1, 2}. NeurAxis is set to transform young lives, offering a scientifically backed, non-invasive solution where only uncertainty existed before^{1, 5, 7}.

Breakthrough for Young Lives: FDA Greenlights First-Ever Treatment for Debilitating Pediatric Gut Disorder

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