NeurAxis, Inc. (NYSE American: NRXS) has secured FDA 510(k) clearance for its IB-Stim device, a non-surgical neuromodulation therapy, marking a significant advancement in treating functional abdominal pain associated with irritable bowel syndrome (IBS) in pediatric patients. The clearance broadens the addressable market for IB-Stim by approximately 75%. This regulatory decision extends the device's indicated age range and refines the treatment protocol, potentially improving patient outcomes and market reach.
Expanded Indication and Treatment Protocol
The FDA's clearance expands the indicated age range for IB-Stim from 11-18 years to 8-21 years. The revised treatment protocol now specifies the use of one device per week for four weeks, replacing the previous protocol of three devices over the same period. IB-Stim delivers gentle electrical impulses to cranial nerve bundles in the ear, modulating the nervous system to alleviate functional abdominal pain associated with IBS.
Clinical and Commercial Impact
Brian Carrico, President and CEO of NeurAxis, stated, "We are excited to receive this new 510(k) clearance for IB-Stim, which expands the IB-Stim addressable market by roughly 75%. Furthermore, we expect devices per patient to increase, as this new FDA clearance states on label use of four devices per patient."
This expanded clearance is expected to drive increased revenue and margin growth for NeurAxis. The company anticipates improved payer coverage and streamlined reimbursement processes due to the establishment of a new CPT Category I code by the American Medical Association, effective January 2026. This code is expected to facilitate easier insurance coverage and higher reimbursement rates compared to temporary codes, enhancing the commercial viability of IB-Stim.
Addressing Unmet Needs in Pediatric IBS
Functional abdominal pain associated with IBS affects a significant portion of the pediatric population. Currently, there are no FDA-approved drug therapies specifically for children with abdominal pain-related disorders of the gut-brain interaction. Off-label pharmacologic treatments often carry the risk of serious side effects and lack robust scientific evidence of efficacy. IB-Stim offers a non-pharmacological alternative with an established safety profile, addressing a critical unmet need in this patient population.
NeurAxis' PENFS Technology
IB-Stim utilizes NeurAxis' proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology. The device is designed to provide targeted neuromodulation, offering a potential solution for managing chronic and debilitating conditions in both children and adults. NeurAxis is currently conducting additional clinical trials of PENFS in various pediatric and adult conditions with significant unmet healthcare needs, underscoring its commitment to advancing evidence-based medicine.
