NeurAxis, Inc. announced today that it has received FDA 510(k) clearance for its IB-Stim device to treat Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia (FD) and FD-related nausea symptoms in patients aged 8 to 21 years. This milestone marks the first treatment ever cleared or approved by the FDA specifically for functional dyspepsia.
The clearance represents the second expanded FDA indication for IB-Stim, following its initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS). According to company officials, this new indication is expected to nearly double NeurAxis's total addressable market.
"This latest FDA clearance represents a pivotal milestone in NeurAxis' growth strategy," said Brian Carrico, President and Chief Executive Officer of NeurAxis. "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."
Addressing an Unmet Medical Need
Functional dyspepsia is a chronic condition characterized by upper abdominal pain or discomfort, often accompanied by symptoms such as early satiety, fullness, and nausea. In pediatric patients, these symptoms can lead to significant complications.
Dr. Adrian Miranda, Chief Medical Officer of NeurAxis, explained the severity of the condition: "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. 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."
The lack of FDA-approved drug therapies for children with abdominal pain-related disorders of gut-brain interaction (DGBIs) has been a significant challenge in pediatric gastroenterology. Currently available pharmacologic treatments are used off-label, often with serious side effects and limited evidence of efficacy.
IB-Stim Technology and Implementation
IB-Stim utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, a non-surgical approach that delivers gentle electrical impulses to cranial nerve bundles in the ear. This neuromodulation therapy aims to address the underlying neurological components of functional gastrointestinal disorders.
The commercial rollout for this expanded indication will begin immediately, with NeurAxis leveraging existing infrastructure. The company noted that the indication will use 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.
Further strengthening the commercial outlook, the American Medical Association recently approved a new CPT Category I code for IB-Stim, which will take effect in January 2026. This development, along with expanding insurance coverage, indicates growing acceptance of the technology among healthcare providers and payers.
Market Impact and Future Directions
As a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions, NeurAxis is positioning itself as a leader in non-invasive, pediatric-focused treatments. The company is currently conducting additional clinical trials of PENFS technology in multiple pediatric and adult conditions with significant unmet healthcare needs.
The expansion into functional dyspepsia treatment represents a significant advancement in pediatric gastroenterology, offering a non-pharmacological option for a condition that affects thousands of children and adolescents. For patients and families who have struggled with limited treatment options, IB-Stim may provide a new approach to managing chronic abdominal pain and associated symptoms.
With this FDA clearance, NeurAxis continues to build on its foundation of evidence-based medicine and innovative technology, potentially transforming the treatment landscape for pediatric functional gastrointestinal disorders.
