NeurAxis (NYSE:NRXS) has announced that the FDA has granted an expanded 510(k) clearance for its IB-Stim device, a non-implanted nerve stimulator used for functional abdominal pain relief. This clearance broadens the device's market reach and increases the potential number of devices used per patient.
IB-Stim Technology
The IB-Stim system employs NeurAxis's proprietary percutaneous electrical nerve field stimulation (PENFS) technology. It is now cleared for functional abdominal pain, building upon its existing clearance for irritable bowel syndrome (IBS)-associated pain in adolescents aged 8-21. The device delivers gentle electrical impulses to cranial nerve bundles in the ear.
Clinical Context and Market Impact
According to NeurAxis, there are currently no FDA-approved drug therapies specifically for children suffering from abdominal pain-related disorders linked to gut-brain interaction. Off-label drug treatments often carry the risk of significant side effects and lack robust scientific evidence supporting their efficacy.
Brian Carrico, President and CEO of NeurAxis, noted that the company has also received expanded payer coverage and a new reimbursement code. The American Medical Association has assigned IB-Stim to CPT Category I, effective January 2026. Carrico anticipates increased revenue and margin growth in the coming quarters as a result of these developments.
Expansion and Future Outlook
"We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly 75%," said Carrico. "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."
