Shares of NeurAxis, Inc. (NRXS) were surging around 170 percent in the pre-market activity on the NYSE after the medical technology announced Tuesday that it has received clearance from the U.S. Food and Drug Administration for IB-Stim for the treatment of Pediatric Functional Dyspepsia.
NeurAxis received FDA 510(k) clearance for IB-Stim to treat Pediatric Functional Abdominal Pain or FAP associated with Functional Dyspepsia, and FD related Nausea Symptoms, in patients aged 8 to 21 years.
According to the firm, the new indication represents the first treatment ever cleared or approved by the FDA related to functional dyspepsia. It is expected to nearly double the Company's total addressable market in non-invasive, pediatric-focused neuromodulation.
The company plans to begin the commercial rollout for the expanded important indication immediately.
The latest clearance is the second successful expanded FDA indication for IB-Stim, following its initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome or IBS.
The company noted that the new indication leverages the same CPT code, insurance coverage, and provider call points as the existing IBS indication, supporting a seamless and capital-efficient go-to-market strategy.
Functional dyspepsia can cause severe abdominal pain and nausea, and in adolescents, it often leads to serious secondary issues like fear of eating, weight loss, and significant dietary restriction.
Brian Carrico, President and Chief Executive Officer of NeurAxis, said, "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."
The company said it is seeing expanded insurance coverage and, most recently, the American Medical Associations approval of a new CPT Category I code for IB-Stim, which will take effect in January 2026.
In the pre-market activity on the NYSE, NeurAxis shares were gaining around 170 percent to trade at $6.1200.
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